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| Name | Class |
|---|---|
| Seinajoki Central Hospital | OTHER |
| Oulu University Hospital | OTHER |
| Jyväskylä Central Hospital | OTHER |
| Kuopio University Hospital |
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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.
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 induce quick remission in patients with early RA, if the remission can be sustained after 6 months on patients continuing the COMBI treatment and can diminish the risk of progression of erosive changes in patients with early RA, and if we can reduce costs of the 2 treatment arms with respect to costs due to the disease.
100 patients with early RA will be included in the study. The patients are randomised into COMBI + placebo or into COMBI +infliximab.
All patients are treated openly with COMBI, starting with a combination of methotrexate, sulfasalazine, hydroxychloroquine and prednisolone. In addition, the patients are randomized into a) infliximab or b) similar placebo. The COMBI treatment will be continued for 2 years, but the infliximab/placebo will be given only during the first 6 months. After 2 years, if the patient is in remission, the prednisolone will be gradually tapered off. If the patient is still in remission, the conventional DMARDs can be sequentially tapered down. If the remission is lost, the last DMARD is reinstituted. If the patient is not in remission of COMBI, after 26 weeks, treatments are free, including the institution of a biological drug.
The patients will be evaluated clinically at week 0, 4, 6, 10, 14, 18, 22 and 26 (at the day of infusion, prior to the infusion) and at months 8, 10, 12, 15, 18, 21, and 24 and at annually thereafter till 10 years.
If a patient has adverse events due to individual drugs in the COMBI, the treatment can be substituted by another DMARD.The disease activity will be measured according to the ACR core set of disease activity.
Radiology of hands (PA projection) and feet (PA projection) at baseline and at 1, 2, 3, 4, 5, 7 and 10 years. We also will record adverse events, sick leaves, loss of income, costs, and work disability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab | Active Comparator | Combination therapy with 3 DMARDs (starting with methotrexate 10-25 mg/week, sulphasalazine 1-2 g/day and hydroxychloroquine 35 mg/kg/week)+ Prednisolon 7.5 mg/day + infliximab 3 mg/kg at weeks 4, 6, 10, 18, 26 |
|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo | Placebo Comparator | Combination therapy with 3 DMARDs (starting with methotrexate 10-25 mg/week, sulphasalazine 1-2 g/day and hydroxychloroquine 25 mg/kg/week)+ Prednisolon 7.5 mg/day + placebo at weeks 4, 6, 10, 18, 26 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission by ACR criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiology (erosions) | 2 years | |
| Sustained remission | Number of patients with sustained ACR remission from month 3 till the end of the study | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| HAQ | Health assessment questionnaire(HAQ) | 1, 2, 3, 4 and 5 years |
| Work disability | Permanent work disability | 2, 3, 4 and 5 years |
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjatta Leirisalo-Repo, MD, Prof | University of Helsinki | Study Director |
| Timo Möttönen, MD, Prof | University of Turku | Study Chair |
| Markku Korpela, MD, PhD | Tampere University | Study Chair |
| Riitta Luosujärvi, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Oili Kaipiainen-Seppänen, MD, PhD | Kuopio University Hospital | Study Chair |
| Markku Kauppi, MD, PhD | Päijänne Tavastia Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hämeenlinna Central Hospital | Hämeenlinna | FI-13530 | Finland | |||
| Rheumatism Foundation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22753402 | Result | Leirisalo-Repo M, Kautiainen H, Laasonen L, Korpela M, Kauppi MJ, Kaipiainen-Seppanen O, Luosujarvi R, Luukkainen R, Karjalainen A, Blafield H, Uutela T, Ilva K, Julkunen HA, Paimela L, Puolakka K, Moilanen E, Hannonen PJ, Mottonen T; NEO-RACo Study Group. Infliximab for 6 months added on combination therapy in early rheumatoid arthritis: 2-year results from an investigator-initiated, randomised, double-blind, placebo-controlled study (the NEO-RACo Study). Ann Rheum Dis. 2013 Jun;72(6):851-7. doi: 10.1136/annrheumdis-2012-201365. Epub 2012 Jun 30. | |
| 25274892 |
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| OTHER |
| Satakunta Central Hospital | OTHER |
| University of Turku | OTHER |
| Rheumatism Foundation Hospital | OTHER |
| Orton Invalid Foundation | OTHER |
| South Carelia Central Hospital | OTHER |
| Lappi Central Hospital | UNKNOWN |
| Kanta-Häme Central Hospital | OTHER_GOV |
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|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo | Drug | 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 |
|
|
| Costs | Cumulative direct and indirect costs at 2 years | 2 |
| Good response | Number of patients with sustained good response (>=ACR50%) from month 3 till the end of study | 5 years |
| Number of arthroplasties | Cumulative number of arthroplasties at 5 years | 5 years |
| Direct and indirect costs | Cumulative direct an indirect costs at 5 years | 5 years |
| Adverse events | Monitoring of safety and adverse events | 10 years |
| ACR Remission | 10 years |
| DAS28 remission | 2, 3, 4, 5, 7 and10 years |
| HAQ | Health assessment questionnaire (HAQ) | 10 years |
| Work disability | Cumulative permanent work disability up till 10 years | 10 years |
| Number of arthroplasties | Cumualite number of arthroplasties by 10 years | 10 years |
| Direct and indirect costs | Cumulative direct and indirect costs by 10 years | 10 years |
| Radiology (erosions) | radiologic changes in hands and feet | 10 years |
| Heinola |
| FI-18120 |
| Finland |
| Helsinki University Central Hospital | Helsinki | FI-00029 HUS | Finland |
| Orton Invalid Foundation Hospital | Helsinki | FI-00280 | Finland |
| Jyväskylä Central Hospital | Jyväskylä | FI-40620 | Finland |
| Kuopio University Hospital | Kuopio | FI-703211 | Finland |
| Lappeenranta Central Hospital | Lappeenranta | FI-53130 | Finland |
| Oulu University Hospital | Oulu | FI-90029 OYS | Finland |
| Satakunta Central Hospital | Rauma | FI-26100 | Finland |
| Rovaniemi Central Hospital | Rovaniemi | FI-96100 | Finland |
| Seinäjoki Central Hospital | Seinäjoki | FI-60220 | Finland |
| Tampere University Hospital | Tampere | FI-33521 | Finland |
| Turku University Central Hospital | Turku | FI-21540 | Finland |
| Result |
| Rantalaiho V, Kautiainen H, Jarvenpaa S, Korpela M, Malmi T, Hannonen P, Kaipiainen-Seppanen O, Yli-Kerttula T, Mottonen T, Mustila A, Karjalainen A, Paimela L, Uutela T, Leirisalo-Repo M; NEO-RACo Study Group. Failure in longterm treatment is rare in actively treated patients with rheumatoid arthritis, but may be predicted by high health assessment score at baseline and by residual disease activity at 3 and 6 months: the 5-year followup results of the randomized clinical NEO-RACo trial. J Rheumatol. 2014 Dec;41(12):2379-85. doi: 10.3899/jrheum.140267. Epub 2014 Oct 1. |
| 23908187 | Result | Rantalaiho V, Kautiainen H, Korpela M, Hannonen P, Kaipiainen-Seppanen O, Mottonen T, Kauppi M, Karjalainen A, Laiho K, Laasonen L, Hakola M, Peltomaa R, Leirisalo-Repo M; NEO-RACo Study Group. Targeted treatment with a combination of traditional DMARDs produces excellent clinical and radiographic long-term outcomes in early rheumatoid arthritis regardless of initial infliximab. The 5-year follow-up results of a randomised clinical trial, the NEO-RACo trial. Ann Rheum Dis. 2014 Nov;73(11):1954-61. doi: 10.1136/annrheumdis-2013-203497. Epub 2013 Aug 1. |
| 40548492 | Derived | Sandstrom T, Kaipiainen-Seppanen O, Mali M, Kauppi M, Kautiainen H, Hannonen P, Yli-Kerttula T, Leirisalo-Repo M, Rantalaiho V. Limited reduction of bone mineral density in patients with early rheumatoid arthritis receiving aggressive treatment: 10 year results of the NEO-RACo study. Scand J Rheumatol. 2025 Nov;54(6):412-420. doi: 10.1080/03009742.2025.2515696. Epub 2025 Jun 23. |
| 34263700 | Derived | Vuolteenaho K, Tuure L, Nieminen R, Laasonen L, Leirisalo-Repo M, Moilanen E; NEO-RACo Study Group. Pretreatment resistin levels are associated with erosive disease in early rheumatoid arthritis treated with disease-modifying anti-rheumatic drugs and infliximab. Scand J Rheumatol. 2022 May;51(3):180-185. doi: 10.1080/03009742.2021.1929456. Epub 2021 Jul 15. |
| 31732558 | Derived | Sandstrom T, Rantalaiho V, Yli-Kerttula T, Kautiainen H, Malmi T, Karjalainen A, Uusitalo T, Julkunen H, Kaipiainen-Seppanen O, Paimela L, Puolakka K, Uutela T, Mottonen T, Hannonen P, Leirisalo-Repo M, Laasonen L, Kauppi M; NEO-RACo Study Group. Cervical Spine Involvement among Patients with Rheumatoid Arthritis Treated Actively with Treat-to-target Strategy: 10-year Results of the NEO-RACo Study. J Rheumatol. 2020 Aug 1;47(8):1160-1164. doi: 10.3899/jrheum.190139. Epub 2019 Nov 15. |
| 30295425 | Derived | Rantalaiho V, Sandstrom T, Koski J, Hannonen P, Mottonen T, Kaipiainen-Seppanen O, Yli-Kerttula T, Kauppi MJ, Uutela T, Malmi T, Julkunen H, Laasonen L, Kautiainen H, Leirisalo-Repo M; NEO-RACo Study Group. Early Targeted Combination Treatment With Conventional Synthetic Disease-Modifying Antirheumatic Drugs and Long-Term Outcomes in Rheumatoid Arthritis: Ten-Year Follow-Up Results of a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1450-1458. doi: 10.1002/acr.23782. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D009271 | Naltrexone |
| D012460 | Sulfasalazine |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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