Status:
UNKNOWN
TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Seinajoki Central Hospital
Oulu University Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
We want to study, whether early treatment with infliximab for 6 months started parallel with the combination therapy of methotrexate, sulphasalazine, hydroxychloroquine and prednisolone (COMBI) can in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00908089
Start Date
March 1 2003
End Date
December 1 2015
Last Update
April 1 2015
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Hämeenlinna Central Hospital
Hämeenlinna, Finland, FI-13530
2
Rheumatism Foundation Hospital
Heinola, Finland, FI-18120
3
Helsinki University Central Hospital
Helsinki, Finland, FI-00029 HUS
4
Orton Invalid Foundation Hospital
Helsinki, Finland, FI-00280