Efficacy of methotrexate on chronic calcium pyrophosphate dihydrate deposition disease (chondrocalcinosis)
| ISRCTN | ISRCTN79343755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79343755 |
| EudraCT/CTIS number | 2007-003479-37 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Axel Finckh
Scientific
Scientific
Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland
Study information
| Study design | Double-blind crossover randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficacy of methotrexate on chronic calcium pyrophosphate dihydrate deposition disease (chondrocalcinosis) - a randomised controlled trial |
| Study hypothesis | 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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | 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. Patients 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 study start date | 01/10/2007 |
| Overall study end date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| 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 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
Study participating centre
Av. Beau Séjour 26
Geneva-14
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
Geneva University Hospitals (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Rue Micheli du Crest
Geneva-14
CH-1211
Switzerland
| Website | http://www.hug-ge.ch/ |
|---|---|
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Hospital/treatment centre
Geneva University Hospitals (Switzerland) - clinical research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | exploratory analysis | 01/02/2007 | Yes | No | |
| Results article | results | 15/10/2014 | Yes | No |
Editorial Notes
13/09/2017: Publication reference added.
