RHEUMATOID ARTHRITIS
Conditions
Interventions
Trade Name: ENBREL
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: HUMIRA
Pharmaceutical Form: Solution for injection
Trade Name: REMICADE
Pharmaceutical Form: Concen
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria - DAS28-CRP>3.2 - Insufficient response to methotrexate at a weekly dose=15mg after at least 3 months - RA radiographic erosions and/or serum rheumatoid factor associated to anti-Cyclic Citrullinated Peptide (Anti-CCP) - Age greater or equal to 18 years - Written informed consent, dated and signed before initiating any trial-related procedure - Affiliation to a social insurance system - Women of child bearing potential, negative ß-HCG assay - Effective method of birth control during the study and continuing 5 months after the end of the study for men and depending for the biotherapy associated for women (referred to the summary product characteristic). 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 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - Previous treatment with or contraindication to a biologic - Previous treatment with or contraindication to triple therapy, salazopyrine, hydroxychloroquine. - Other inflammatory arthritis except those associated to Sjögren’s syndrome - Contraindication to all biologics or to methotrexate, sulfasalazine and hydroxychloroquine - Corticosteroids at a dose >15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion - Absence of tuberculosis screening for patients in the biologic arm - Patient who cannot be followed during 12 months - Pregnancy, breastfeeding, desire of pregnancy in the 12 months - Drug addiction, addiction to alcohol - Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment - Women of child bearing potential, unless they are using an effective method of birth control - Patient under law protection - Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate whether or not biologics are more effective than triple therapy in methotrexate-IR patients with RA.;Secondary Objective: 1 - To compare the safety profile of the two strategies. 2 - To compare the drug retention rate of the two strategies and the adhesion to treatment at inclusion, 6, and 12 months. 3 - To compare the change in the clinical disease activity index (CDAI) of the two strategies at 3, 6, 9 and 12 months. 4 - To compare the DAS 28 CRP of the two strategies at 3, 6, 9 and 12 months. 5 - To compare the ACR of the two strategies and the boolean remission at 3, 6, 9 and 12 months. 6 - To compare the radiographic progression of the two strategies between 0 and 12 months. 7 - To compare the change of comedications at 3, 6, 9 and 12 months. 8 - To compare the patient quality of life in the two groups. 9 - To assess the impact of rheumatoid arthritis on sexuality in the two groups. ;Primary end point(s): Low disease activity (DAS28-CRP=3.2) and a daily dose = 7, 5 mg of equivalent prednisone under the randomized strategy after, at last, 11 months of follow up.;Timepoint(s) of evaluation of this end point: at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Serious adverse events rate 2- Blood concentrations of hydroxychloroquine , salazopyrine and methotrexate in the triple therapy group and methotrexate, biologic and anti-drug antibody in the other group at 6, and 12 months 3- Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months. 4- DAS 28 CRP score at inclusion, 3, 6, 9 and12 months. 5- 2010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and boolean remission at 3, 6, 9 and 12 months. 6- Modified Sharp Van der Hejde score at inclusion and at 12 month. 7- Change in comedications (corticostéroides, dose of methotrexate, subcutaneous use of methotrexate), treatment observance. 8- SF36 score, Rapid score, HAQ score, RAID score, at inclusion, 3, 6, 9 and at 12 months. 9- QUALISEX score at inclusion, 6 months and at 12 months. ;Timepoint(s) of evaluation of this end point: 1- at each visit 2- at inclusion, 6, and 12 months 3- at each visit 4- at each visit 5- at 3, 6, 9 and 12 months. 6- at inclusion and at 12 month. 7- at each visit. 8- at each visit 9- at inclusion, 6 months and at 12 months. | — |
Countries
France, Monaco
Contacts
Public ContactChristine GEILLER
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed