To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.

Official Title
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To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Conditions
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Active Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Treatment I
* Drug: Treatment II
* Drug: Treatment III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects able and willing to give written informed consent and is available for entire study. Male or female ≥ 18 years old Willing and able to comply with the study protocol visits, assessments and accessible for follow up Known Diagnosed Rheumatoid arthritis 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: Subjects who are pregnant or intend to become pregnant during the study 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. 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. Active infection requiring systemic treatment Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1: Sunpharma1505 (Low dose) and Placebo<br> | Drug: Treatment I<br>* Sunpharma1505 and Placebo<br>|
| Experimental: Treatment II: Sunpharma1505 (High Dose) and Placebo<br> | Drug: Treatment II<br>* Sunpharma1505 and Placebo<br>|
| Active Comparator: Treatment III: Reference1505 and Placebo<br> | Drug: Treatment III<br>* Reference1505 and Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good/Moderate European League Against Rheumatism Responders |  | week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |