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

Sun Pharma

Status and phase: Terminated; Phase 3

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Treatment I; Drug: Treatment III; Drug: Treatment II

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534896

CLR_15_05

Details and patient eligibility

About

This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Treatment 1: Sunpharma1505 (Low dose) and Placebo

Experimental group

Treatment:

Drug: Treatment I

Treatment II: Sunpharma1505 (High Dose) and Placebo

Experimental group

Treatment:

Drug: Treatment II

Treatment III: Reference1505 and Placebo

Active Comparator group

Treatment:

Drug: Treatment III