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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 13 April 2015
Main ID:  NCT00908089
Date of registration: 22/05/2009
Prospective Registration: No
Primary sponsor: Helsinki University
Public title: TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis NEO-RACo
Scientific title: Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis
Date of first enrolment: March 2003
Target sample size: 100
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00908089
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Finland
Contacts
Name:     Marjatta Leirisalo-Repo, MD, Prof
Address: 
Telephone:
Email:
Affiliation:  Helsinki University
Name:     Riitta Luosujärvi, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Helsinki University Central Hospital
Name:     Oili Kaipiainen-Seppänen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Kuopio University Hospital
Name:     Markku Kauppi, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Paijat-Hame Central Hospital
Name:     Markku Korpela, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Tampere University
Name:     Timo Möttönen, MD, Prof
Address: 
Telephone:
Email:
Affiliation:  Turku University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab
Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo
Primary Outcome(s)
Remission by ACR criteria [Time Frame: 2 years]
Secondary Outcome(s)
Costs [Time Frame: 2]
Radiology (erosions) [Time Frame: 2 years]
Sustained remission [Time Frame: 2 years]
Secondary ID(s)
NEO-RACo
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Central Hospital of Kanta-Hame
Jyväskylä Central Hospital
Kuopio University Hospital
Lappi Central Hospital
Orton Invalid Foundation
Oulu University Hospital
Rheumatism Foundation Hospital
Satakunta Central Hospital
Seinajoki Central Hospital
South Karelia central hospital
University of Turku
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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