Trial Outcomes & Findings for Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA (NCT NCT03172325)
NCT ID: NCT03172325
Last Updated: 2021-02-02
Results Overview
The primary variables are the percentage of patients with DAS28-EULAR Good and Moderate Responses at week 24 compared with Humira. Moderate response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is equal to or more than 3.2 or decrement of 0.6-1.2 while patient's DAS score is equal to or below 5.1. Good response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is below 3.2. We used the Disease Activity Score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS28-ESR) to assess disease activity in patients with rheumatoid arthritis. This score ranges from 2 to 10, and higher values indicate higher disease activity. DAS28-ESR is calculated with the following formula: DAS28-ESR= (0.56\*√(Tender Joint Count)+0.28\*√(Swollen Joint Count)+0.7\*ln(ESR)+0.014\*(global health))
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
Week 24
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
CinnaGen Adalimumab
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
CinnaGen Adalimumab
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Positive PPD
|
1
|
0
|
|
Overall Study
Poor Compliance
|
1
|
1
|
Baseline Characteristics
Because of the missing data in the health assessment questionnaire, row population differs from the overall.
Baseline characteristics by cohort
| Measure |
CinnaGen Adalimumab
n=68 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=68 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=68 Participants
|
63 Participants
n=68 Participants
|
122 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=68 Participants
|
5 Participants
n=68 Participants
|
14 Participants
n=136 Participants
|
|
Age, Continuous
|
48.29 years
STANDARD_DEVIATION 12.72 • n=68 Participants
|
47.59 years
STANDARD_DEVIATION 11.48 • n=68 Participants
|
47.94 years
STANDARD_DEVIATION 12.08 • n=136 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=68 Participants
|
60 Participants
n=68 Participants
|
118 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=68 Participants
|
8 Participants
n=68 Participants
|
18 Participants
n=136 Participants
|
|
Region of Enrollment
Iran
|
68 Participants
n=68 Participants
|
68 Participants
n=68 Participants
|
136 Participants
n=136 Participants
|
|
Patient assessment of pain
|
67.21 units on a scale
STANDARD_DEVIATION 23.51 • n=68 Participants
|
70.22 units on a scale
STANDARD_DEVIATION 21.93 • n=68 Participants
|
68.71 units on a scale
STANDARD_DEVIATION 22.70 • n=136 Participants
|
|
Physician's global assessment of disease activity
|
68.97 units on a scale
STANDARD_DEVIATION 17.38 • n=68 Participants
|
70.44 units on a scale
STANDARD_DEVIATION 17.68 • n=68 Participants
|
69.71 units on a scale
STANDARD_DEVIATION 17.48 • n=136 Participants
|
|
Patient global assessment of disease activity
|
70.15 units on a scale
STANDARD_DEVIATION 20.35 • n=68 Participants
|
70.74 units on a scale
STANDARD_DEVIATION 22.21 • n=68 Participants
|
70.44 units on a scale
STANDARD_DEVIATION 21.23 • n=136 Participants
|
|
Swollen joint count, 28 joints
|
9.96 Swollen joints
STANDARD_DEVIATION 7.39 • n=68 Participants
|
9.46 Swollen joints
STANDARD_DEVIATION 6.98 • n=68 Participants
|
9.71 Swollen joints
STANDARD_DEVIATION 7.17 • n=136 Participants
|
|
Tender joint count, 28 joints
|
9.46 Tender joints
STANDARD_DEVIATION 8.23 • n=68 Participants
|
9.66 Tender joints
STANDARD_DEVIATION 7.97 • n=68 Participants
|
9.56 Tender joints
STANDARD_DEVIATION 8.08 • n=136 Participants
|
|
Erythrocyte Sedimentation Rate (ESR)
|
32.65 mm/h
STANDARD_DEVIATION 21.24 • n=68 Participants
|
31.12 mm/h
STANDARD_DEVIATION 24.01 • n=68 Participants
|
31.88 mm/h
STANDARD_DEVIATION 22.60 • n=136 Participants
|
|
C-Reactive Protein (CRP)
|
21.40 mg/L
STANDARD_DEVIATION 25.98 • n=68 Participants
|
18.90 mg/L
STANDARD_DEVIATION 23.90 • n=68 Participants
|
20.12 mg/L
STANDARD_DEVIATION 24.87 • n=136 Participants
|
|
DAS28-ESR
|
5.51 units on a scale
STANDARD_DEVIATION 1.24 • n=68 Participants
|
5.47 units on a scale
STANDARD_DEVIATION 1.28 • n=68 Participants
|
5.49 units on a scale
STANDARD_DEVIATION 1.26 • n=136 Participants
|
|
Health Assessment Questionnaire (HAQ) Disability Index
|
2.25 units on a scale
n=65 Participants • Because of the missing data in the health assessment questionnaire, row population differs from the overall.
|
2.38 units on a scale
n=68 Participants • Because of the missing data in the health assessment questionnaire, row population differs from the overall.
|
2.38 units on a scale
n=133 Participants • Because of the missing data in the health assessment questionnaire, row population differs from the overall.
|
PRIMARY outcome
Timeframe: Week 24The primary variables are the percentage of patients with DAS28-EULAR Good and Moderate Responses at week 24 compared with Humira. Moderate response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is equal to or more than 3.2 or decrement of 0.6-1.2 while patient's DAS score is equal to or below 5.1. Good response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is below 3.2. We used the Disease Activity Score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS28-ESR) to assess disease activity in patients with rheumatoid arthritis. This score ranges from 2 to 10, and higher values indicate higher disease activity. DAS28-ESR is calculated with the following formula: DAS28-ESR= (0.56\*√(Tender Joint Count)+0.28\*√(Swollen Joint Count)+0.7\*ln(ESR)+0.014\*(global health))
Outcome measures
| Measure |
CinnaGen Adalimumab
n=64 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=64 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Percentage of Patients With DAS28-EULAR Good and Moderate Responses at Week 24
|
63 percentage of participants
|
63 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24ACR20, ACR50, and ACR70 Response Rates are considered as respectively an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score from Baseline at Week 24.
Outcome measures
| Measure |
CinnaGen Adalimumab
n=64 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=64 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Percentage of Patients Achieving ACR20, ACR50 and ACR70 Response Rates at Week 24
Percentage of Patients achieving ACR50
|
77 percentage of participants
|
75 percentage of participants
|
|
Percentage of Patients Achieving ACR20, ACR50 and ACR70 Response Rates at Week 24
Percentage of Patients achieving ACR70
|
47 percentage of participants
|
53 percentage of participants
|
|
Percentage of Patients Achieving ACR20, ACR50 and ACR70 Response Rates at Week 24
Percentage of Patients achieving ACR20
|
92 percentage of participants
|
89 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Quality of life is assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming, arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. There are 20 questions in the mentioned 8 sections. In each section, the highest score is considered as the main answer. Scores should be between 0 and 3 and the final answer is the average of scores relating to all sections. An increased score indicates a worsening of the disability. The disability index of Health Assessment Questionnaire (HAQ) at week 24 is reported.
Outcome measures
| Measure |
CinnaGen Adalimumab
n=64 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=64 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Health Assessment Questionnaire (HAQ) Disability Index at Week 24.
|
0.25 score on a scale
Interval 0.0 to 0.63
|
0.19 score on a scale
Interval 0.0 to 0.63
|
SECONDARY outcome
Timeframe: From the time of first treatment up to the last dose of study treatment; 24 weeks.The incidence of adverse events at each visit is recorded based on patients' reports, vital signs, physical examinations, and laboratory tests for systemic safety, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing.
Outcome measures
| Measure |
CinnaGen Adalimumab
n=68 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=68 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
The Incidence of Adverse Events
|
23 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 24Number of Participants with Anti-Drug Antibodies (ADA) at Week 24. The ELISA method was used for immunogenicity assessments of adalimumab.
Outcome measures
| Measure |
CinnaGen Adalimumab
n=53 Participants
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=55 Participants
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA)
|
5 Participants
|
2 Participants
|
Adverse Events
CinnaGen Adalimumab
Serious events: 2 serious events
Other events: 23 other events
Deaths: 1 deaths
AbbVie Adalimumab
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CinnaGen Adalimumab
n=68 participants at risk
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=68 participants at risk
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Infections and infestations
Peritoneal tuberculosis
|
1.5%
1/68
|
0.00%
0/68
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68
|
1.5%
1/68
|
Other adverse events
| Measure |
CinnaGen Adalimumab
n=68 participants at risk
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
AbbVie Adalimumab
n=68 participants at risk
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.
Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.
Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.
Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/68
|
2.9%
2/68
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/68
|
1.5%
1/68
|
|
General disorders
Injection site reaction
|
8.8%
6/68
|
17.6%
12/68
|
|
Infections and infestations
Respiratory infection
|
2.9%
2/68
|
10.3%
7/68
|
|
Infections and infestations
Sinusitis
|
1.5%
1/68
|
5.9%
4/68
|
|
General disorders
Flu-like symptoms
|
4.4%
3/68
|
5.9%
4/68
|
|
Gastrointestinal disorders
Nausea
|
5.9%
4/68
|
2.9%
2/68
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/68
|
1.5%
1/68
|
|
Nervous system disorders
Headache
|
5.9%
4/68
|
5.9%
4/68
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
2/68
|
4.4%
3/68
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68
|
1.5%
1/68
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/68
|
2.9%
2/68
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/68
|
1.5%
1/68
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.9%
2/68
|
0.00%
0/68
|
|
General disorders
Fever
|
1.5%
1/68
|
1.5%
1/68
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/68
|
4.4%
3/68
|
|
General disorders
Inflammation localized
|
1.5%
1/68
|
0.00%
0/68
|
|
Reproductive system and breast disorders
Breast pain
|
2.9%
2/68
|
0.00%
0/68
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68
|
0.00%
0/68
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.5%
1/68
|
0.00%
0/68
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/68
|
1.5%
1/68
|
|
General disorders
Oedema
|
1.5%
1/68
|
0.00%
0/68
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/68
|
1.5%
1/68
|
|
Investigations
Weight increased
|
1.5%
1/68
|
0.00%
0/68
|
|
General disorders
Fatigue
|
0.00%
0/68
|
1.5%
1/68
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/68
|
1.5%
1/68
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/68
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.5%
1/68
|
0.00%
0/68
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator (PI) may publish results provided a copy of the written publication is received by the sponsor at least 30 days in advance for review and comment. If the parties disagree, PI agrees to meet with the sponsor before submission to resolve any disagreement. It is also agreed that publishing any reports from data is under the condition of the subject's consent. Any reports are highly confidential, and the PI does not have the permission to reveal them without the sponsor's agreement.
- Publication restrictions are in place
Restriction type: OTHER