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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 November 2021
• Main ID: NCT02534896
• Date of registration: 25/08/2015
• Prospective Registration: Yes
• Primary sponsor: Sun Pharmaceutical Industries Limited
• Public title: To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
• Scientific title: To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
• Date of first enrolment: November 2015
• Target sample size: 150
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02534896
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Belgium, Netherlands

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Active Rheumatoid Arthritis

Intervention(s)

Drug: Treatment I

Drug: Treatment III

Drug: Treatment II

Primary Outcome(s)

Good/Moderate European League Against Rheumatism Responders [Time Frame: week 1]

Secondary Outcome(s)

Good European League Against Rheumatism -Responders [Time Frame: Day 8]

Good/Moderate European League Against Rheumatism Responders [Time Frame: Day 15]

Good European League Against Rheumatism Responders [Time Frame: Day 15]

Secondary ID(s)

CLR_15_05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02534896