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

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.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab

methotrexate 10-25 mg/week, sulfasalazine 1-2 g/day, hydroxychloroquine 35 mg/kg/week, prednisolone 7.5 mg/day, and infliximab 3 mg/kg during first 6 months

DRUG

Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo

methotrexate 10-25 mg/week, sulfasalazine 1-2 g/day, hydroxychloroquine 35 mg/kg/week, prednisolone 7.5 mg/day, and placebo infusion during first 6 months

Sponsors & Collaborators

• Seinajoki Central Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Jyväskylä Central Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• University of Turku

  collaborator OTHER

• Rheumatism Foundation Hospital

  collaborator OTHER

• Orton Invalid Foundation

  collaborator OTHER

• South Carelia Central Hospital

  collaborator OTHER

• Lappi Central Hospital

  collaborator UNKNOWN

• Kanta-Häme Central Hospital

  collaborator OTHER_GOV

• University of Helsinki

  lead OTHER

Principal Investigators

• Marjatta Leirisalo-Repo, MD, Prof · University of Helsinki

• Timo Möttönen, MD, Prof · University of Turku

• Markku Korpela, MD, PhD · Tampere University

• Riitta Luosujärvi, MD, PhD · Helsinki University Central Hospital

• Oili Kaipiainen-Seppänen, MD, PhD · Kuopio University Hospital

• Markku Kauppi, MD, PhD · Päijänne Tavastia Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-03-31

Primary Completion

2007-05-31

Completion

2015-12-31

Countries

• Finland

Study Locations