Active Rheumatoid Arthritis
Conditions
Brief summary
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
Interventions
DRUGTreatment I
Sunpharma1505 and Placebo
DRUGTreatment II
Sunpharma1505 and Placebo
DRUGTreatment III
Reference1505 and Placebo
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects able and willing to give written informed consent and is available for entire study. 2. Male or female ≥ 18 years old 3. Willing and able to comply with the study protocol visits, assessments and accessible for follow up 4. Known Diagnosed Rheumatoid arthritis 5. Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator
Exclusion criteria
1. Subjects who are pregnant or intend to become pregnant during the study 2. Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody \[anti-HCV\]), and / or a positive Human immunodeficiency virus (HIV) antibody. 3. Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents. 4. Active infection requiring systemic treatment 5. Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good/Moderate European League Against Rheumatism Responders | week 1 |
Secondary
| Measure | Time frame |
|---|---|
| Good European League Against Rheumatism -Responders | Day 8 |
| Good/Moderate European League Against Rheumatism Responders | Day 15 |
| Good European League Against Rheumatism Responders | Day 15 |
Countries
Belgium, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment I: Sunpharma1505 (Low Dose) and Placebo solution for injection/infusion Day 1 and 15 | 49 |
| Treatment II: Sunpharma1505 (High Dose) and Placebo solution for injection/infusion Day 1 and 15 | 52 |
| Treatment III: Reference1505 and Placebo solution for injection/infusion Day 1 and 15 | 49 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 |
| Overall Study | Insufficient therapeutic response | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 13.79 | 56.4 years STANDARD_DEVIATION 10.74 | 56.7 years STANDARD_DEVIATION 11.18 | 56.1 years STANDARD_DEVIATION 11.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 49 Participants | 43 Participants | 138 Participants |
| Sex: Female, Male Female | 38 Participants | 42 Participants | 35 Participants | 115 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 14 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 42 / 49 | 46 / 52 | 39 / 49 |
| serious Total, serious adverse events | 4 / 49 | 1 / 52 | 2 / 49 |
Outcome results
Primary
Good/Moderate European League Against Rheumatism Responders
Time frame: week 1
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment I : Sunpharma1505 (Low Dose) and Placebo | Good/Moderate European League Against Rheumatism Responders | 42 Participants |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Good/Moderate European League Against Rheumatism Responders | 45 Participants |
| Treatment III: Reference1505 and Placebo | Good/Moderate European League Against Rheumatism Responders | 32 Participants |
p-value: 0.018Hochberg and Gatekeeping
p-value: 0.007Hochberg and Gatekeeping
Secondary
Good European League Against Rheumatism Responders
Time frame: Day 15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment I : Sunpharma1505 (Low Dose) and Placebo | Good European League Against Rheumatism Responders | 24 Participants |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Good European League Against Rheumatism Responders | 33 Participants |
| Treatment III: Reference1505 and Placebo | Good European League Against Rheumatism Responders | 21 Participants |
p-value: 0.573Hochberg and Gatekeeping
p-value: 0.374Hochberg and Gatekeeping
Secondary
Good European League Against Rheumatism -Responders
Time frame: Day 8
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment I : Sunpharma1505 (Low Dose) and Placebo | Good European League Against Rheumatism -Responders | 21 Participants |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Good European League Against Rheumatism -Responders | 26 Participants |
| Treatment III: Reference1505 and Placebo | Good European League Against Rheumatism -Responders | 10 Participants |
p-value: 0.028Hochberg and Gatekeeping
p-value: 0.003Hochberg and Gatekeeping
Secondary
Good/Moderate European League Against Rheumatism Responders
Time frame: Day 15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment I : Sunpharma1505 (Low Dose) and Placebo | Good/Moderate European League Against Rheumatism Responders | 42 Participants |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Good/Moderate European League Against Rheumatism Responders | 43 Participants |
| Treatment III: Reference1505 and Placebo | Good/Moderate European League Against Rheumatism Responders | 42 Participants |
p-value: 0.96Hochberg and Gatekeeping
p-value: 0.339Hochberg and Gatekeeping