Efficacy of methotrexate on chronic calcium pyrophosphate dihydrate deposition disease (chondrocalcinosis)

Not Applicable

Completed

Conditions: Chronic calcium pyrophosphate dihydrate (CPPD) arthropathy
Musculoskeletal Diseases
Other crystal arthropathies

Registration Number: ISRCTN79343755

Lead Sponsor: Geneva University Hospitals (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Definite chronic calcium pyrophosphate dihydrate (CPPD) deposition disease using the McCarty diagnostic criteria
2. Recurrent mono- or oligo-arthrits ('pseudogout') (at least three flares/six months) or persistent poly-arthritis
3. Unsatisfactory response on at least one non-steroidal anti-inflammatory drug (NSAID) or low dose glucocorticoids (defined by the patient), OR contraindication to NSAIDs and glucocorticoids (defined by the physician)
4. Informed consent
5. Patients 18 years and over, either sex

Exclusion Criteria

1. Contraindication to methotrexate (MTX):
1.1. Hepatic failure
1.2. Important alcohol consumption
1.3. Severe renal failure
1.4. Haematological disease
1.5. Acute infection
2. Diagnosis of rheumatoid arthritis, connective tissue disease, psoriatic arthritis, gout or any other chronic or recurrent disease associated with oligo- or poly-arthritis
3. Inability to fill out a questionnaire in the local language
4. Pregnancy (negative pregnancy test), lactation, or refusal to use an effective form of contraception for all participants in child-baring age

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be arthritic disease activity, measured by the DAS44 (disease activity score on 44 joints), and pain levels, measured by a patient visual analogue scale.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be:<br>1. Number of acute arthritis flares<br>2. Patient?s global assessment<br>3. Function of the target joints<br>4. Erythrocyte sedimentation rates<br>5. Number of tender and swollen joints<br>6. Number of analgesic pills<br>7. Safety and tolerability of methotrexate