Chronic Chondrocalcinosis
Conditions
Interventions
Trade Name: Metoject
Product Name: Metoject
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Sponsors
University Hospital of Geneva
University Hospital Geneva, Switzerland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients recruited to participate in this trial will satisfy the following criteria; Patients must have a definite diagnosis of Crystal Pyrophosphate Dihydrate (CPPD) disease using the Mc Carty diagnostic criteria. Patients who have had an unsatisfactory response to at least one non steroidal anti-inflammatory medication (NSAID) or low dose steroid. Contraindications to the use of NSAID and glucocorticoid medication Recurrent mono or oligoarthritis (pseudogout) (experiencing at least three flares in 6 months) or persistent polyarthritis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from study participation for the following reasons; Any contraindication to Methotrexate (hepatic failure, alcohol consumption, severe renal failure, haematological diseases, or acute infection A diagnosis of Rheumatoid Arthritis, Connective Tissue Disease or Gout. Literacy difficulties which will compromise their ability to fill out the study questionnaires Patients whose ability to give informed consent may be compromised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is currently no specific medication to slow or prevent progression of chronic chondrocalcinosis, and no randomized trials have established the efficacy of antirheumatic therapies in this condition. The primary objective will be to determine the efficacy and safety of methotrexate, a well tolerated anti-rheumatic drug prescribed for other rheumatic diseases. Outcomes measured will include, the level of disease activity, pain, and number of arthritis flares reported. Patients will be randomized to receive either methotrexate or placebo for three months, followed by a washout period of two months. The crossover treatment will then be prescribed for a futher three months. ;Secondary Objective: The secondary outcomes will include; Patients global assessment of disease activity The function of the targeted joints Erythrocyte sedimentation rate Serologic markers of inflammation Duration of morning stiffness Number of tender and swollen joints Number of Analgesic tablets taken during the course of the trial;Primary end point(s): No specific outcome measures have been validated for CPPD deposition disease. Instruments developed and validated for other rheumatic diseases will be utilized. The clinical presentation of complicated CPPD is similar to other common rheumatic diseases such as gout (hence the term “pseudogout”) or polyarthritis, which should make the use of outcome measures for these diseases good instruments for chondrocalcinosis as well. Patients level of disease activity will be measured using the DAS 44. This is a composite outcome measure which includes the numbe of swollen joints, the number of tender joints, and the erythrocyte sedimentation rate (ESR). Disease activity: The DAS44 is a validated assessment tool of disease activity in rheumatoid arthritis that has been used in many other chronic arthritides. The computation of the Disease Activity score with 44 joints: (DAS44)(10): DAS44 = 0.54·v(Tender count) + 0.065·(Swollen co | — |
Countries
Ireland
Outcome results
None listed