EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA).

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2018
INTERVENTION: Trade Name: ORENCIA Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: ABATACEPT CAS Number: 332348‐12‐6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 250‐ Trade Name: Dolquine Pharmaceutical Form: Coated tablet INN or Proposed INN: HYDROXYCHLOROQUINE CAS Number: 118‐42‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ CONDITION: PALINDROMIC RHEUMATISM Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine. Primary end point(s): Achievement of classification criteria of rheumatoid arthritis (EULAR/ACR 2010) at any time during the follow‐up (up to 24 months). Secondary Objective: frequency and intensity of joint attacks. Adverse events and Effects on ACPA titres Timepoint(s) of evaluation of this end point: At any time during the follow‐up (up to 24 months) SECONDARY OUTCOME: ; Secondary end point(s): ‐Number and intensity of joint attacks.; ‐Adverse Events.; ‐Effects on ACPA serum and anti‐CarP antibodies.; Timepoint(s) of evaluation of this end point: At any time during the follow‐up (up to 24 months) INCLUSION CRITERIA: Patients with PR according to Guerne and Weissman modified criteria (18) and with: ‐ Disease evolution > 3 months and < 24 months. ‐ ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence). ‐ Greater than 18 years of age. 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 98 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Epistemonikos ID: fc05bbbf1078eab7f19c54a831dda47531ae70c5
First added on: Mar 23, 2022