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

Active Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02534896
• Other study ID #: CLR_15_05
• Status: Terminated
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: June 2018

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Active Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Treatment I
Sunpharma1505 and Placebo
• Treatment II
Sunpharma1505 and Placebo
• Treatment III
Reference1505 and Placebo

Locations

Country	Name	City	State
Belgium	Sun Pharma Site 17	Brussels
Belgium	Sun Pharma Site 18	Brussels
Belgium	Sun Pharma Site 21	Brussels
Belgium	Sun Pharma Site 22	Brussels
Belgium	Sun Pharma Site 23	Brussels
Belgium	Sun Pharma Site 16	Leuven
Belgium	Sun Pharma Site 19	Liege
Belgium	Sun Pharma Site 20	Merksem
Netherlands	Sun Pharma Site 11	Amsterdam
Netherlands	Sun Pharma Site 9	Amsterdam
Netherlands	Sun Pharma Site 6	Enschede
Netherlands	Sun Pharma Site 4	Heerlen
Netherlands	Sun Pharma Site 7	Hilversum
Netherlands	Sun Pharma Site 2	Leeuwarden
Netherlands	Sun Pharma Site 8	Lelystad
Netherlands	Sun Pharma Site 10	Rotterdam
Netherlands	Sun Pharma Site 3	Rotterdam
Netherlands	Sun Pharma Site 5	Sneek
Netherlands	Sun Pharma Site 14	Uden
Netherlands	Sun pharma Site 01	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good/Moderate European League Against Rheumatism Responders		week 1
Secondary	Good European League Against Rheumatism -Responders		Day 8
Secondary	Good/Moderate European League Against Rheumatism Responders		Day 15
Secondary	Good European League Against Rheumatism Responders		Day 15