TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The FIN-RACo trial is an investigator initiated multicenter (n=15 centers in Finland) prospective study on the treatment of patients with early rheumatoid arthritis (RA) with combination therapy with disease modifying antirheumatic drugs starting with methotrexate, sulphasalazine, hydroxychloroquine and prednisolone (COMBI). During the first 6 months, the patients are randomized to treatment with infliximab/placebo added on the combination treatment. The study is prospective for 5 years, with extension to 10 years. The target is to induce remission in both treatment arms. To reach this target, the investigators use frequent changes of doses and anti-rheumatic drugs and use of intra-articular glucocorticoid injections. The primary endpoints are the proportions of patients with remission at 2 and 5 years in both treatment arms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University; University of Helsinki
• Collaborators: Central Hospital of Kanta-Hame; Jyväskylä Central Hospital; Kanta-Häme Central Hospital; Kuopio University Hospital; Lappi Central Hospital; Orton Invalid Foundation; Oulu University Hospital; Rheumatism Foundation Hospital; Satakunta Central Hospital; Seinajoki Central Hospital; South Carelia Central Hospital; South Karelia central hospital; University of Turku
• Treatments: Antirheumatic Agents; Hydroxychloroquine; Infliximab; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Naltrexone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sulfasalazine

Criteria

Inclusion Criteria:

• Diagnosis of RA fulfilling the ACR classification criteria for RA

• Patients within age group of 18-60 years

• Patients not permanently work disabled or retired

• Duration of symptoms < 12 months, and who have not received DMARD previously

• Patients with active disease (see below)

• Criteria for active disease at entry:

• > 6 swollen joints (66 joint count)

• > 6 tender joints (68 joint count)

• duration of early morning stiffness > 45 min and/or ESR > 30 mm/h and/or CRP > 20 mg/l

Exclusion Criteria:

• Previous treatment with DMARDs

• Previous treatment with oral glucocorticoids during the previous 6 months

• Less than 30 days from previous intra-articular injection with corticosteroids

• Allergy to sulphonamides

• Allergy to acetylsalicylic acid

• Allergy to methotrexate

• Allergy to antimalarials

• Previous treatment with biologicals

• Serum creatinine value > upper limit of normal (registered in 2 different blood samples)

• Serum transaminase levels > 2x upper limit of normal (registered in 2 different samples)

• Known/previous malignancy excluding basalioma or in situ cervical cancer >5 years previously

• Cardiac failure (NYHA III-IV)

• Previous history of tuberculosis and/or exposition to tuberculosis and/or typical changes of previous/active tuberculosis in chest radiology

• Active infection

• Pregnancy

• Leukopenia (WBC < 4 x 109/l)

• Thrombocytopenia (platelets < 100 x 109/l)

• Active peptic ulcer

• Type I or type II diabetes under poor control

• Heavy use of alcohol

• Fertile women not practising contraception or who are planning pregnancy

• Male patients wishing to have children during the therapy

• Other autoimmune rheumatic disease

• Other chronic disease which judged by the physician could influence the patient's compliance or intervene the study course

• Patient is not cooperative