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

• Status: Terminated
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Global FZE

Criteria

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.