Hand OA AND Methotrexate Use

NCT ID: NCT01927484

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-07
• Study Completion Date: 2020-03-11

Brief Summary

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.

The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA.

Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.

Conditions

Reduction in Pain; Reduction of Inflammation; Improvement in Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

methotrexate

25mg oral methotrexate tablets

Group Type: EXPERIMENTAL

25 mg/week oral methotrexate tablets

Intervention Type: DRUG

active oral methotrexate drug

placebo

25 mg/week placebo tablets

Group Type: PLACEBO_COMPARATOR

25mg/week oral placebo tablets

Intervention Type: DRUG

placebo comparator oral drug

Interventions

25 mg/week oral methotrexate tablets

active oral methotrexate drug

Intervention Type: DRUG

25mg/week oral placebo tablets

placebo comparator oral drug

Intervention Type: DRUG

Other Intervention Names

interventional drug

Eligibility Criteria

Inclusion Criteria

• primary knee osteoarthritis
• persistent pain
• synovitis

Exclusion Criteria

• rheumatoid arthritis
• gout and pseudogout
• traumatic arthritis
• other secondary arthritis
• renal disease
• liver disease

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Anna Abou-Raya

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

alexmed1391963211975

Identifier Type: -

Identifier Source: org_study_id