Condition category
Musculoskeletal Diseases
Date applied
11/01/2008
Date assigned
10/03/2008
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Axel Finckh

ORCID ID

Contact details

Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Methotrexate is efficient in controlling symptoms and signs of chronic chondrocalcinosis.

Ethics approval

Ethics approval received from Swissmedic, the Swiss Agency for Therapeutic Products on the 2nd July 2007 (ref: 2007DR3150; protocol: 06-167)

Study design

Double-blind crossover randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic calcium pyrophosphate dihydrate (CPPD) arthropathy

Intervention

Patients will be randomised to receive either methotrexate (10 - 15 mg/week intramuscular [im] injections) or placebo during an initial treatment period of three months, followed by a wash-out period of one month, and a subsequent treatment period of three months with the alternative regimen. The total duration of follow-up will be eight months (three months in one arm and two months wash-out and three months in the other arm).

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate

Primary outcome measures

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

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

Overall trial start date

01/10/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/10/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Ireland, Switzerland

Trial participating centre

Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland

Sponsor information

Organisation

Geneva University Hospitals (Switzerland)

Sponsor details

Rue Micheli du Crest
Geneva-14
CH-1211
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

Geneva University Hospitals (Switzerland) - clinical research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Exploratory analysis in http://www.ncbi.nlm.nih.gov/pubmed/17265505

Publication citations

  1. Exploratory analysis

    Chollet-Janin A, Finckh A, Dudler J, Guerne PA, Methotrexate as an alternative therapy for chronic calcium pyrophosphate deposition disease: an exploratory analysis., Arthritis Rheum., 2007, 56, 2, 688-692, doi: 10.1002/art.22389.

Additional files

Editorial Notes