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

November 18, 2021 updated by: Sun Pharmaceutical Industries Limited
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, 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
      • Leuven, Belgium
        • Sun Pharma Site 16
      • Liege, Belgium
        • Sun Pharma Site 19
      • Merksem, Belgium
        • Sun Pharma Site 20
  • Netherlands
      • Amsterdam, Netherlands
        • Sun Pharma Site 11
      • Amsterdam, Netherlands
        • Sun Pharma Site 9
      • Enschede, Netherlands
        • Sun Pharma Site 6
      • Heerlen, Netherlands
        • Sun Pharma Site 4
      • Hilversum, Netherlands
        • Sun Pharma Site 7
      • Leeuwarden, Netherlands
        • Sun Pharma Site 2
      • Lelystad, Netherlands
        • Sun Pharma Site 8
      • Rotterdam, Netherlands
        • Sun Pharma Site 10
      • Rotterdam, Netherlands
        • Sun Pharma Site 3
      • Sneek, Netherlands
        • Sun Pharma Site 5
      • Uden, Netherlands
        • Sun Pharma Site 14
      • Utrecht, Netherlands
        • Sun Pharma Site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Good/Moderate European League Against Rheumatism Responders
Time Frame: week 1
week 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Good European League Against Rheumatism -Responders
Time Frame: Day 8
Day 8
Good/Moderate European League Against Rheumatism Responders
Time Frame: Day 15
Day 15
Good European League Against Rheumatism Responders
Time Frame: Day 15
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_15_05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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