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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Active Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment 1: Sunpharma1505 (Low dose) and Placebo

Group Type EXPERIMENTAL

Treatment I

Intervention Type DRUG

Sunpharma1505 and Placebo

Treatment II: Sunpharma1505 (High Dose) and Placebo

Group Type EXPERIMENTAL

Treatment II

Intervention Type DRUG

Sunpharma1505 and Placebo

Treatment III: Reference1505 and Placebo

Group Type ACTIVE_COMPARATOR

Treatment III

Intervention Type DRUG

Reference1505 and Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treatment I

Sunpharma1505 and Placebo

Intervention Type DRUG

Treatment II

Sunpharma1505 and Placebo

Intervention Type DRUG

Treatment III

Reference1505 and Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Utrecht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Netherlands

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLR_15_05

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

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

Interventions

Treatment I

Treatment II

Treatment III

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sun Pharmaceutical Industries Limited

Responsible Party

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

Countries

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Other Identifiers

CLR_15_05