Efficacy of methotrexate on chronic calcium pyrophosphate dihydrate deposition disease (chondrocalcinosis)
| ISRCTN | ISRCTN79343755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79343755 |
| Clinical Trials Information System (CTIS) | 2007-003479-37 |
| Protocol serial number | N/A |
| Sponsor | Geneva University Hospitals (Switzerland) |
| Funder | Geneva University Hospitals (Switzerland) - clinical research grant |
- Submission date
- 11/01/2008
- Registration date
- 10/03/2008
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Axel Finckh
Scientific
Scientific
Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind crossover randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of methotrexate on chronic calcium pyrophosphate dihydrate deposition disease (chondrocalcinosis) - a randomised controlled trial |
| Study objectives | Methotrexate is efficient in controlling symptoms and signs of chronic chondrocalcinosis. |
| Ethics approval(s) | Ethics approval received from Swissmedic, the Swiss Agency for Therapeutic Products on the 2nd July 2007 (ref: 2007DR3150; protocol: 06-167) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Secondary outcomes will be: |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Ireland
- Switzerland
Study participating centre
Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2014 | Yes | No | |
| Other publications | exploratory analysis | 01/02/2007 | Yes | No |
Editorial Notes
13/09/2017: Publication reference added.
