RANDOMIZED CONTROLLED CLINICAL TRIAL EVALUATING METHOTREXATE OR LEFLUNOMIDE + TARGETED THERAPY VERSUS METHOTREXATE OR LEFLUNOMIDE + SULFASALAZINE + HYDROXYCHLOROQUINE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INSUFFICIENT RESPONSE TO METHOTREXATE OR LEFLUNOMIDE (The BIO-3 trial)

Conditions

Rheumatoid Arthritis

Brief summary

Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.

Detailed description

Serious adverse events rate, Blood concentrations of hydroxychloroquine, leflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group at 6, and 12 months, Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months, DAS 28 CRP score at inclusion, 3, 6, 9 and12 months, 52010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and Boolean remission at 3, 6, 9 and 12 months, Modified Sharp Van der Hejde score at inclusion and at 12 month, Change in comedications (corticosteroids, dose of methotrexate or leflunomide, subcutaneous use of methotrexate), treatment observance, SF36 score, Rapid score, HAQ score, RAID score, FACIT score at inclusion, 3, 6, 9 and at 12 months, QUALISEX score at inclusion, 6 months and at 12 months, Medico-economic evaluation results at inclusion, 3, 6, 9 and at 12 months

Related papers

No related papers found yet.

Interventions

DRUGETANERCEPT

DRUGTOCILIZUMAB

DRUGBARICITINIB

DRUGABATACEPT

DRUGUPADACITINIB

DRUGMETHOTREXATE

DRUGINFLIXIMAB

DRUGSARILUMAB

DRUGCERTOLIZUMAB PEGOL

DRUGGOLIMUMAB

DRUGRITUXIMAB

DRUGADALIMUMAB

DRUGLEFLUNOMIDE

DRUGTOFACITINIB

DRUGSULFASALAZINE

DRUGFILGOTINIB

DRUGHYDROXYCHLOROQUINE SULFATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.	—

Secondary

Measure	Time frame
Serious adverse events rate, Blood concentrations of hydroxychloroquine, leflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group at 6, and 12 months, Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months, DAS 28 CRP score at inclusion, 3, 6, 9 and12 months, 52010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and Boolean remission at 3, 6, 9 and 12 months, Modified Sharp Van der Hejde score at inclusion and at 12 month, Change in comedications (corticosteroids, dose of methotrexate or leflunomide, subcutaneous use of methotrexate), treatment observance, SF36 score, Rapid score, HAQ score, RAID score, FACIT score at inclusion, 3, 6, 9 and at 12 months, QUALISEX score at inclusion, 6 months and at 12 months, Medico-economic evaluation results at inclusion, 3, 6, 9 and at 12 months	—

Measure

Time frame

Serious adverse events rate, Blood concentrations of hydroxychloroquine, leflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group at 6, and 12 months, Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months, DAS 28 CRP score at inclusion, 3, 6, 9 and12 months, 52010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and Boolean remission at 3, 6, 9 and 12 months, Modified Sharp Van der Hejde score at inclusion and at 12 month, Change in comedications (corticosteroids, dose of methotrexate or leflunomide, subcutaneous use of methotrexate), treatment observance, SF36 score, Rapid score, HAQ score, RAID score, FACIT score at inclusion, 3, 6, 9 and at 12 months, QUALISEX score at inclusion, 6 months and at 12 months, Medico-economic evaluation results at inclusion, 3, 6, 9 and at 12 months

—

Countries

France

Outcome results

None listed