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

Phase 3

Terminated

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: Treatment I; Drug: Treatment II; Drug: Treatment III

• Registration Number: NCT02534896
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Study Start: 2015-11
• Primary Completion: 2018-03
• Study Completion: 2018-06
• Results First Submitted: 2019-05-02
• Results First Submitted QC: 2019-11-01
• Results First Posted: 2019-11-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 1: Sunpharma1505 (Low dose) and Placebo	Treatment I	-
Treatment II: Sunpharma1505 (High Dose) and Placebo	Treatment II	-
Treatment III: Reference1505 and Placebo	Treatment III	-

Primary Outcome Measures

Name	Time	Method
Good/Moderate European League Against Rheumatism Responders	week 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Sun Pharma Site 23; 🇧🇪 Brussels, Belgium

Sun Pharma Site 20; 🇧🇪 Merksem, Belgium

Sun Pharma Site 16; 🇧🇪 Leuven, Belgium

Sun Pharma Site 7; 🇳🇱 Hilversum, Netherlands

Sun Pharma Site 17; 🇧🇪 Brussels, Belgium

Sun Pharma Site 18; 🇧🇪 Brussels, Belgium

Sun Pharma Site 19; 🇧🇪 Liege, Belgium

Sun Pharma Site 11; 🇳🇱 Amsterdam, Netherlands

Sun Pharma Site 5; 🇳🇱 Sneek, Netherlands

Sun Pharma Site 6; 🇳🇱 Enschede, Netherlands

Sun Pharma Site 22; 🇧🇪 Brussels, Belgium

Sun Pharma Site 8; 🇳🇱 Lelystad, Netherlands

Sun Pharma Site 21; 🇧🇪 Brussels, Belgium

Sun Pharma Site 9; 🇳🇱 Amsterdam, Netherlands

Sun Pharma Site 4; 🇳🇱 Heerlen, Netherlands

Sun Pharma Site 2; 🇳🇱 Leeuwarden, Netherlands

Sun Pharma Site 10; 🇳🇱 Rotterdam, Netherlands

Sun Pharma Site 3; 🇳🇱 Rotterdam, Netherlands

Sun Pharma Site 14; 🇳🇱 Uden, Netherlands

Sun pharma Site 01; 🇳🇱 Utrecht, Netherlands