Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Health Condition 1: null- Juvenile Rheumatoid Arthritis

• Registration Number: CTRI/2011/05/001734
• Lead Sponsor: Ipca Laboratories Ltd Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-04-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 77

Inclusion Criteria

Male and female subjects in the age range of 4 to 16 years (both inclusive).

-Subjects who have a diagnosis of JRA according to the ACR (American College of Rheumatology) criteria for JRA.

-Active pauciarticular (i.e. inflammation in fewer than 5 joints) or polyarticular JRA (i.e. equal to or greater than 5 swollen joint or equal to or greater than 3 joint with limitation of movement accompanied by either pain on motion or tenderness or both which could be of the same joint and rheumatoid factor positive or negative) without systemic onset that persists for at least 6 weeks and inadequately controlled by NSAIDs plus any DMARDs.

-Ready to give consent/assesnt

Exclusion Criteria

-Subjects having active systemic course of JRA(i.e. persistent intermittent fever with or without erythematosus rash, hepatosplenomegally , lymphadenopathy , serositis or other organ involvement)
-Current inflammatory diseases or history of diseases other than juvenile rheumatoid arthritis (like lupus erythematosus, vasculitis, dermatomyositis, scleroderma, rheumatic fever, anterior uveitis, fibromyalgia, SLE infectious arthritis, psoriasis or ankylosing spondylitis, sacroiliitis with inflammatory bowel disease).
-Subjects who had undergone joint surgery within the preceding two months of the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified