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

Primary Purpose

Active Rheumatoid Arthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Treatment I
Treatment II
Treatment III
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Pharma Site 17
  • Sun Pharma Site 18
  • Sun Pharma Site 21
  • Sun Pharma Site 22
  • Sun Pharma Site 23
  • Sun Pharma Site 16
  • Sun Pharma Site 19
  • Sun Pharma Site 20
  • Sun Pharma Site 11
  • Sun Pharma Site 9
  • Sun Pharma Site 6
  • Sun Pharma Site 4
  • Sun Pharma Site 7
  • Sun Pharma Site 2
  • Sun Pharma Site 8
  • Sun Pharma Site 10
  • Sun Pharma Site 3
  • Sun Pharma Site 5
  • Sun Pharma Site 14
  • Sun pharma Site 01

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment 1: Sunpharma1505 (Low dose) and Placebo

Treatment II: Sunpharma1505 (High Dose) and Placebo

Treatment III: Reference1505 and Placebo

Arm Description

Outcomes

Primary Outcome Measures

Good/Moderate European League Against Rheumatism Responders

Secondary Outcome Measures

Good European League Against Rheumatism -Responders
Good/Moderate European League Against Rheumatism Responders
Good European League Against Rheumatism Responders

Full Information

First Posted
August 25, 2015
Last Updated
November 18, 2021
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02534896
Brief Title
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Official Title
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1: Sunpharma1505 (Low dose) and Placebo
Arm Type
Experimental
Arm Title
Treatment II: Sunpharma1505 (High Dose) and Placebo
Arm Type
Experimental
Arm Title
Treatment III: Reference1505 and Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Treatment I
Intervention Description
Sunpharma1505 and Placebo
Intervention Type
Drug
Intervention Name(s)
Treatment II
Intervention Description
Sunpharma1505 and Placebo
Intervention Type
Drug
Intervention Name(s)
Treatment III
Intervention Description
Reference1505 and Placebo
Primary Outcome Measure Information:
Title
Good/Moderate European League Against Rheumatism Responders
Time Frame
week 1
Secondary Outcome Measure Information:
Title
Good European League Against Rheumatism -Responders
Time Frame
Day 8
Title
Good/Moderate European League Against Rheumatism Responders
Time Frame
Day 15
Title
Good European League Against Rheumatism Responders
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sun Pharma Site 17
City
Brussels
Country
Belgium
Facility Name
Sun Pharma Site 18
City
Brussels
Country
Belgium
Facility Name
Sun Pharma Site 21
City
Brussels
Country
Belgium
Facility Name
Sun Pharma Site 22
City
Brussels
Country
Belgium
Facility Name
Sun Pharma Site 23
City
Brussels
Country
Belgium
Facility Name
Sun Pharma Site 16
City
Leuven
Country
Belgium
Facility Name
Sun Pharma Site 19
City
Liege
Country
Belgium
Facility Name
Sun Pharma Site 20
City
Merksem
Country
Belgium
Facility Name
Sun Pharma Site 11
City
Amsterdam
Country
Netherlands
Facility Name
Sun Pharma Site 9
City
Amsterdam
Country
Netherlands
Facility Name
Sun Pharma Site 6
City
Enschede
Country
Netherlands
Facility Name
Sun Pharma Site 4
City
Heerlen
Country
Netherlands
Facility Name
Sun Pharma Site 7
City
Hilversum
Country
Netherlands
Facility Name
Sun Pharma Site 2
City
Leeuwarden
Country
Netherlands
Facility Name
Sun Pharma Site 8
City
Lelystad
Country
Netherlands
Facility Name
Sun Pharma Site 10
City
Rotterdam
Country
Netherlands
Facility Name
Sun Pharma Site 3
City
Rotterdam
Country
Netherlands
Facility Name
Sun Pharma Site 5
City
Sneek
Country
Netherlands
Facility Name
Sun Pharma Site 14
City
Uden
Country
Netherlands
Facility Name
Sun pharma Site 01
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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