Trial Outcomes & Findings for Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467)) (NCT NCT01163292)
NCT ID: NCT01163292
Last Updated: 2018-07-06
Results Overview
The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Recruitment status
COMPLETED
Target enrollment
220 participants
Primary outcome timeframe
Weeks 0, 26, and 52
Results posted on
2018-07-06
Participant Flow
Participant milestones
| Measure |
Adalimumab
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
114
|
|
Overall Study
COMPLETED
|
65
|
92
|
|
Overall Study
NOT COMPLETED
|
41
|
22
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
9
|
0
|
|
Overall Study
Adverse Event
|
6
|
0
|
|
Overall Study
Initiation of biological therapy
|
0
|
15
|
|
Overall Study
Sufficient response to adalimumab
|
8
|
0
|
|
Overall Study
Refusal to receive adalimumab
|
7
|
0
|
|
Overall Study
Economic reasons
|
6
|
0
|
|
Overall Study
No further visits
|
5
|
7
|
Baseline Characteristics
Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
Baseline characteristics by cohort
| Measure |
Adalimumab
n=106 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=114 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 12.3 • n=107 Participants
|
55.3 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Body weight
|
55.46 kg
STANDARD_DEVIATION 8.99 • n=99 Participants
|
57.53 kg
STANDARD_DEVIATION 11.08 • n=107 Participants
|
56.53 kg
STANDARD_DEVIATION 10.16 • n=206 Participants
|
|
Rheumatoid arthritis duration
|
1.290 years
STANDARD_DEVIATION 0.428 • n=99 Participants
|
1.316 years
STANDARD_DEVIATION 0.438 • n=107 Participants
|
1.303 years
STANDARD_DEVIATION 0.433 • n=206 Participants
|
|
Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate)
Yes
|
58 participants
n=99 Participants
|
51 participants
n=107 Participants
|
109 participants
n=206 Participants
|
|
Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate)
No
|
48 participants
n=99 Participants
|
63 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Concomitant Glucocorticoid Use
Yes
|
33 participants
n=99 Participants
|
30 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Concomitant Glucocorticoid Use
No
|
73 participants
n=99 Participants
|
84 participants
n=107 Participants
|
157 participants
n=206 Participants
|
|
Rheumatoid Factor
Positive
|
60 participants
n=99 Participants
|
71 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Rheumatoid Factor
Negative
|
46 participants
n=99 Participants
|
43 participants
n=107 Participants
|
89 participants
n=206 Participants
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
|
0.29 units on a scale
STANDARD_DEVIATION 0.34 • n=99 Participants
|
0.25 units on a scale
STANDARD_DEVIATION 0.33 • n=107 Participants
|
0.27 units on a scale
STANDARD_DEVIATION 0.34 • n=206 Participants
|
|
Disease Activity Score
|
2.89 units on a scale
STANDARD_DEVIATION 1.10 • n=99 Participants
|
2.74 units on a scale
STANDARD_DEVIATION 1.11 • n=107 Participants
|
2.81 units on a scale
STANDARD_DEVIATION 1.11 • n=206 Participants
|
|
Modified Total Sharp Score (mTSS)
|
15.61 units on a scale
STANDARD_DEVIATION 22.19 • n=99 Participants
|
16.47 units on a scale
STANDARD_DEVIATION 22.30 • n=107 Participants
|
16.05 units on a scale
STANDARD_DEVIATION 22.20 • n=206 Participants
|
|
Matrix Metalloprotease (MMP-3)
Male
|
149.95 ng/mL
STANDARD_DEVIATION 114.81 • n=99 Participants
|
113.70 ng/mL
STANDARD_DEVIATION 135.15 • n=107 Participants
|
130.50 ng/mL
STANDARD_DEVIATION 125.92 • n=206 Participants
|
|
Matrix Metalloprotease (MMP-3)
Female
|
86.94 ng/mL
STANDARD_DEVIATION 113.09 • n=99 Participants
|
88.88 ng/mL
STANDARD_DEVIATION 182.09 • n=107 Participants
|
87.94 ng/mL
STANDARD_DEVIATION 152.09 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 26, and 52Population: All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.
The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Outcome measures
| Measure |
Adalimumab
n=91 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=95 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Disease Activity Score (DAS28)
Week 0
|
2.93 units on a scale
Standard Deviation 1.05
|
2.73 units on a scale
Standard Deviation 1.04
|
|
Disease Activity Score (DAS28)
Week 26
|
2.72 units on a scale
Standard Deviation 1.12
|
3.17 units on a scale
Standard Deviation 1.11
|
|
Disease Activity Score (DAS28)
Week 52
|
2.70 units on a scale
Standard Deviation 1.08
|
3.20 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Weeks 0, 26, and 52Population: All participants with post-baseline MMP-3 data, using LOCF imputation method
MMP-3 level in serum. Positive = \>/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Outcome measures
| Measure |
Adalimumab
n=93 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=96 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Matrix Metalloprotease-3 (MMP-3)
Week 0 Positive
|
36 units on a scale
|
30 units on a scale
|
|
Matrix Metalloprotease-3 (MMP-3)
Week 0 Negative
|
57 units on a scale
|
66 units on a scale
|
|
Matrix Metalloprotease-3 (MMP-3)
Week 26 Positive
|
34 units on a scale
|
35 units on a scale
|
|
Matrix Metalloprotease-3 (MMP-3)
Week 26 Negative
|
59 units on a scale
|
61 units on a scale
|
|
Matrix Metalloprotease-3 (MMP-3)
Week 52 Positive
|
21 units on a scale
|
43 units on a scale
|
|
Matrix Metalloprotease-3 (MMP-3)
Week 52 Negative
|
72 units on a scale
|
53 units on a scale
|
SECONDARY outcome
Timeframe: Week 0 to Week 52Population: All participants with post-baseline mTSS data, using LOCF imputation method
Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Sum of scores was given as total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Outcome measures
| Measure |
Adalimumab
n=86 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=96 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
|
0.8 units on a scale
Standard Deviation 3.9
|
0.6 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Weeks 0, 26, and 52Population: All participants with post-baseline HAQ-DI data, using LOCF imputation method
Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Outcome measures
| Measure |
Adalimumab
n=85 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=82 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 0
|
0.27 units on a scale
Standard Deviation 0.32
|
0.24 units on a scale
Standard Deviation 0.33
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 26
|
0.20 units on a scale
Standard Deviation 0.32
|
0.24 units on a scale
Standard Deviation 0.36
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 52
|
0.20 units on a scale
Standard Deviation 0.29
|
0.26 units on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Week 0 to Week 52Population: All participants registered
Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Outcome measures
| Measure |
Adalimumab
n=106 Participants
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=114 Participants
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
51 participants
|
39 participants
|
Adverse Events
Adalimumab
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Non-Adalimumab
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=106 participants at risk
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=114 participants at risk
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Gastroenteritis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Herpes zoster
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Pyelonephritis acute
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Sepsis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
Other adverse events
| Measure |
Adalimumab
n=106 participants at risk
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
|
Non-Adalimumab
n=114 participants at risk
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
|
|---|---|---|
|
Eye disorders
Cataract
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
5/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
General disorders
Injection site reaction
|
3.8%
4/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
General disorders
Pyrexia
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Hepatobiliary disorders
Liver disorder (enzyme elevation)
|
0.94%
1/106 • Week 0 to Week 52
|
1.8%
2/114 • Week 0 to Week 52
|
|
Infections and infestations
Bronchitis
|
2.8%
3/106 • Week 0 to Week 52
|
1.8%
2/114 • Week 0 to Week 52
|
|
Infections and infestations
Gastroenteritis
|
2.8%
3/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Herpes zoster
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
13/106 • Week 0 to Week 52
|
7.0%
8/114 • Week 0 to Week 52
|
|
Infections and infestations
Pharyngitis
|
0.94%
1/106 • Week 0 to Week 52
|
1.8%
2/114 • Week 0 to Week 52
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Oral herpes
|
1.9%
2/106 • Week 0 to Week 52
|
2.6%
3/114 • Week 0 to Week 52
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Investigations
White blood cell count decreased
|
1.9%
2/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/106 • Week 0 to Week 52
|
2.6%
3/114 • Week 0 to Week 52
|
|
Nervous system disorders
Headache
|
2.8%
3/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.8%
4/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Vascular disorders
Hypertension
|
0.94%
1/106 • Week 0 to Week 52
|
1.8%
2/114 • Week 0 to Week 52
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Eye disorders
Dry eye
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Chelitis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Vomiting
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Gastrointestinal disorders
Pancreatic enlargement
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
General disorders
Malaise
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Hepatobiliary disorders
Driug-induced liver injury
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Acute sinusitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Bronchopneumonia
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Cystitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Genital candidiasis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Rhinitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Sinusitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Infections and infestations
Bronchitis bacterial
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Injury, poisoning and procedural complications
Contusion
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Investigations
Liver function test abnormal
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.94%
1/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Nervous system disorders
Dizziness
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Nervous system disorders
Dysgeusia
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Renal and urinary disorders
Urinary retention
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/106 • Week 0 to Week 52
|
0.88%
1/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
0.94%
1/106 • Week 0 to Week 52
|
0.00%
0/114 • Week 0 to Week 52
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER