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

Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis: A Double Blind, Randomized Comparison with Methotrexate alone

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/05/001734

Enrollment

154

Registered

2011-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Juvenile Rheumatoid Arthritis

Interventions

Intervention1: Hydroxychloroquine: 100mg/Day oral for 24 weeks Control Intervention1: Methotrexate 2.5, 5.7,5 or 10 mg: Methotrexate oral weekly for 24 weeks

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Patients with a 30 percent improvement from baseline in at least 3 of the 6 following variables with no more than one of the remaining variables worsening by more than 30percent The core set are; 1.Physician?s global assessment of disease activity 2.Parent?s/patient?s (if appropriate in age) global assessment of overall well-being 3.Functional ability by CHAQ Disability Index 4.Number of joints with active arthritis 5.Number of joints with limited range of motion; and 6.ESR. Timepoint: Week 0, 4,8,12,16,20 and 24 [Delete]	—

Measure

Time frame

Patients with a 30 percent improvement from baseline in at least 3 of the 6 following variables with no more than one of the remaining variables worsening by more than 30percent The core set are; 1.Physician?s global assessment of disease activity 2.Parent?s/patient?s (if appropriate in age) global assessment of overall well-being 3.Functional ability by CHAQ Disability Index 4.Number of joints with active arthritis 5.Number of joints with limited range of motion; and 6.ESR. Timepoint: Week 0, 4,8,12,16,20 and 24 [Delete]

—

Secondary

Measure	Time frame
ACR Pedi 50, ACR Pedi 70, JAFAR-C, JAFAR-PTimepoint: ACR Pedi 50, ACR Pedi 70: Week 0, 4,8,12,16,20 and 24 JAFAR-C, JAFAR-P: Week 0 and Week 24	—

Countries

India

Contacts

Public ContactMr Nitin Chandurkar

anil.pareek@ipca.com022-66474641

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026