Trial Outcomes & Findings for Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II) (NCT NCT00595413)
NCT ID: NCT00595413
Last Updated: 2016-02-17
Results Overview
ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
311 participants
Primary outcome timeframe
Week 26
Results posted on
2016-02-17
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
78
|
78
|
79
|
|
Overall Study
COMPLETED
|
69
|
73
|
70
|
75
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
8
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
3
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
5
|
1
|
5
|
0
|
Baseline Characteristics
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
Baseline characteristics by cohort
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
53.0 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
53.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 11.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
259 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants who received at least 1 study treatment dose.
ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26
|
46.1 percentage of participants
|
44.9 percentage of participants
|
57.7 percentage of participants
|
70.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants who received at least 1 study treatment dose.
ACR50-CRP response is defined as \>=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26
|
14.5 percentage of participants
|
29.5 percentage of participants
|
33.3 percentage of participants
|
38.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants who received at least 1 study treatment dose.
ACR70-CRP response is defined as \>=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26
|
5.3 percentage of participants
|
12.8 percentage of participants
|
12.8 percentage of participants
|
17.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants who received at least 1 study treatment dose.
The EULAR response criteria evaluate change in DAS28 scores represented as "good response", "moderate response", or "no response" considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have "good" or "moderate" EULAR response if at the time of assessment, their DAS28 score was less than or equal to (\<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (\>) 0.6; or if at the time of assessment, their DAS28 score was \>5.1 and improvement from baseline in their DAS28 score was \>1.2.
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26
|
59.2 percentage of participants
|
64.1 percentage of participants
|
67.9 percentage of participants
|
81.0 percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38Population: ITT population included all randomized participants who received at least 1 study treatment dose.
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 Participants
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 Participants
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
38 participants
|
49 participants
|
49 participants
|
50 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
2 participants
|
4 participants
|
7 participants
|
3 participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Atacicept 150 mg With Loading Dose
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Atacicept 150 mg Without Loading Dose
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Adalimumab
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=76 participants at risk
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 participants at risk
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 participants at risk
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 participants at risk
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.5%
2/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Pericarditis
|
1.3%
1/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.3%
1/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypertension
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Placebo
n=76 participants at risk
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
|
Atacicept 150 mg With Loading Dose
n=78 participants at risk
Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
|
Atacicept 150 mg Without Loading Dose
n=78 participants at risk
Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
|
Adalimumab
n=79 participants at risk
Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
5.3%
4/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.4%
5/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.7%
6/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
6/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.6%
2/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.3%
5/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
7.6%
6/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
6.4%
5/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
1.3%
1/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.6%
2/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
3.9%
3/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.5%
2/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.5%
2/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypertension
|
5.3%
4/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.6%
2/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
4/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.3%
1/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
3/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
3/76 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.1%
4/78 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
2.5%
2/79 • From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
- Publication restrictions are in place
Restriction type: OTHER