Trial Outcomes & Findings for To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis (NCT NCT02534896)
NCT ID: NCT02534896
Last Updated: 2021-11-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
week 1
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
52
|
49
|
|
Overall Study
COMPLETED
|
45
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
|
Overall Study
Insufficient therapeutic response
|
2
|
0
|
0
|
Baseline Characteristics
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Treatment I: Sunpharma1505 (Low Dose) and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 Participants
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.74 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 1Population: Intent-to-treat population
Outcome measures
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 Participants
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Good/Moderate European League Against Rheumatism Responders
|
42 Participants
|
45 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 8Population: intent-to-treat
Outcome measures
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 Participants
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Good European League Against Rheumatism -Responders
|
21 Participants
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 15Outcome measures
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 Participants
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Good/Moderate European League Against Rheumatism Responders
|
42 Participants
|
43 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Day 15Outcome measures
| Measure |
Treatment I : Sunpharma1505 (Low Dose) and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 Participants
solution for injection/infusion Day 1 and 15
|
Treatment III: Reference1505 and Placebo
n=49 Participants
solution for injection/infusion Day 1 and 15
|
|---|---|---|---|
|
Good European League Against Rheumatism Responders
|
24 Participants
|
33 Participants
|
21 Participants
|
Adverse Events
Treatment I: Sunpharma1505 (Low Dose) and Placebo
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Treatment II: Sunpharma1505 (High Dose) and Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Treatment III: Reference1505 and Placebo
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment I: Sunpharma1505 (Low Dose) and Placebo
n=49 participants at risk
Treatment I: Treatment I and Placebo
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 participants at risk
Treatment II: Treatment II and Placebo
|
Treatment III: Reference1505 and Placebo
n=49 participants at risk
Treatment III: Treatment III and Placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
1/49 • Week 12
|
0.00%
0/52 • Week 12
|
0.00%
0/49 • Week 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/49 • Week 12
|
0.00%
0/52 • Week 12
|
2.0%
1/49 • Week 12
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/49 • Week 12
|
1.9%
1/52 • Week 12
|
0.00%
0/49 • Week 12
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Week 12
|
0.00%
0/52 • Week 12
|
0.00%
0/49 • Week 12
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Week 12
|
0.00%
0/52 • Week 12
|
0.00%
0/49 • Week 12
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/49 • Week 12
|
0.00%
0/52 • Week 12
|
2.0%
1/49 • Week 12
|
Other adverse events
| Measure |
Treatment I: Sunpharma1505 (Low Dose) and Placebo
n=49 participants at risk
Treatment I: Treatment I and Placebo
|
Treatment II: Sunpharma1505 (High Dose) and Placebo
n=52 participants at risk
Treatment II: Treatment II and Placebo
|
Treatment III: Reference1505 and Placebo
n=49 participants at risk
Treatment III: Treatment III and Placebo
|
|---|---|---|---|
|
Vascular disorders
Hot flush
|
8.2%
4/49 • Week 12
|
11.5%
6/52 • Week 12
|
12.2%
6/49 • Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
4/49 • Week 12
|
3.8%
2/52 • Week 12
|
8.2%
4/49 • Week 12
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • Week 12
|
3.8%
2/52 • Week 12
|
4.1%
2/49 • Week 12
|
|
General disorders
Fatigue
|
12.2%
6/49 • Week 12
|
11.5%
6/52 • Week 12
|
10.2%
5/49 • Week 12
|
|
Gastrointestinal disorders
Nausea
|
18.4%
9/49 • Week 12
|
11.5%
6/52 • Week 12
|
2.0%
1/49 • Week 12
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
6/49 • Week 12
|
9.6%
5/52 • Week 12
|
8.2%
4/49 • Week 12
|
|
Nervous system disorders
Headache
|
16.3%
8/49 • Week 12
|
17.3%
9/52 • Week 12
|
12.2%
6/49 • Week 12
|
|
Infections and infestations
Influenza
|
6.1%
3/49 • Week 12
|
3.8%
2/52 • Week 12
|
0.00%
0/49 • Week 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49 • Week 12
|
5.8%
3/52 • Week 12
|
8.2%
4/49 • Week 12
|
|
Skin and subcutaneous tissue disorders
Hyeprhidrosis
|
2.0%
1/49 • Week 12
|
11.5%
6/52 • Week 12
|
6.1%
3/49 • Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER