Methotrexate in Symptomatic Knee Osteoarthritis

NCT01654575 | Completed DMC

• 1 other identifier: alexmed116662981
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.

Conditions

Osteoarthritis

Keywords

Methotrexate; Knee Osteoarthritis; Synovitis; Pain reduction; Function scores

Outcome Measures

Primary Outcomes (2)

• Pain reduction

  4 months

• Pain reduction

  16 weeks

Secondary Outcomes (1)

• Improvement in physical function scores

  4 months

Study Arms (2)

Methotrexate

EXPERIMENTAL

25mg/week orally

Drug: Methotrexate

Placebo

ACTIVE COMPARATOR

Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.

Drug: Placebo

Interventions

Methotrexate DRUG

Methotrexate 25mg/week for 16 weeks

Methotrexate

Placebo DRUG

Placebo tablets once a week for 16 weeks

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis
• pain not responding to the usual therapy
• synovitis

You may not qualify if:

• any other inflammatory conditions,
• hepatic and renal insufficiency

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Synovitis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Abou-Raya, MD

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

EG (1)