Rheumatoid ArthritisPhase 4NEO-RACoNCT00908089
TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis
A Phase 4 study testing Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab in people with Rheumatoid Arthritis, run by University of Helsinki at 13 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 13 sitesFinland
- Study dates
- Mar 2003to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- > 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Finland13 sites
Hämeenlinna Central Hospital
Hämeenlinna, FI-13530
Rheumatism Foundation Hospital
Heinola, FI-18120
Helsinki University Central Hospital
Helsinki, FI-00029 HUS
Orton Invalid Foundation Hospital
Helsinki, FI-00280
Jyväskylä Central Hospital
Jyväskylä, FI-40620
Kuopio University Hospital
Kuopio, FI-703211
Lappeenranta Central Hospital
Lappeenranta, FI-53130
Oulu University Hospital
Oulu, FI-90029 OYS
Satakunta Central Hospital
Rauma, FI-26100
Rovaniemi Central Hospital
Rovaniemi, FI-96100
Seinäjoki Central Hospital
Seinäjoki, FI-60220
Tampere University Hospital
Tampere, FI-33521
Turku University Central Hospital
Turku, FI-21540
About this study
Official title: Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis
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.
Read the 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 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab, Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo
- Keywords
- rheumatoid arthritis, methotrexate, sulfasalazine, hydroxychloroquine, infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximabDrug
Also called Trexan, Salazopyrin, Oxiklorin, Prednison, Remicade
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
Trexan+Salazopyrin+Oxiklorin+prednisolone + placeboDrug
Also called Trexan, Salazopyrin, Oxiklorin, Prednison, 0.9% NaCl
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab |
| 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 Receives: Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission by ACR criteria
Measured: 2 years
Secondary outcomes (3)
Radiology (erosions)
Measured: 2 years
Sustained remission
Number of patients with sustained ACR remission from month 3 till the end of the study
Measured: 2 years
Costs
Cumulative direct and indirect costs at 2 years
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startMar 2003
- Primary completionMay 2007
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Seinajoki Central Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Kuopio University Hospital, Satakunta Central Hospital, University of Turku, Rheumatism Foundation Hospital, Orton Invalid Foundation, South Carelia Central Hospital, Lappi Central Hospital, Kanta-Häme Central Hospital
- Responsible party
- Principal investigator, Marjatta Leirisalo-Repo, University of Helsinki
- Investigators
- Marjatta Leirisalo-Repo, MD, Prof, Study director, University of HelsinkiTimo Möttönen, MD, Prof, Study chair, University of TurkuMarkku Korpela, MD, PhD, Study chair, Tampere UniversityRiitta Luosujärvi, MD, PhD, Study chair, Helsinki University Central HospitalOili Kaipiainen-Seppänen, MD, PhD, Study chair, Kuopio University HospitalMarkku Kauppi, MD, PhD, Study chair, Päijänne Tavastia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908089
- Sponsor's protocol ID
- NEO-RACo
- Acronym
- NEO-RACo
- Status last verified
- Mar 2015
- First submitted
- 22 May 2009
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22753402Rantalaiho 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.
PubMed 25274892Rantalaiho 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.
PubMed 23908187Sandstrom 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.
PubMed 40548492Vuolteenaho 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.
PubMed 34263700Sandstrom 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.
PubMed 31732558Rantalaiho 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.
PubMed 30295425
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00908089
- Acronym / sponsor ID
- NEO-RACo / NEO-RACo
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, methotrexate, sulfasalazine, hydroxychloroquine, infliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Seinajoki Central Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Kuopio University Hospital, Satakunta Central Hospital, University of Turku, Rheumatism Foundation Hospital, Orton Invalid Foundation, South Carelia Central Hospital, Lappi Central Hospital, Kanta-Häme Central Hospital
- Study start
- Mar 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab | Active comparator | Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximabCombination 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 | Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placeboCombination 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximabAlso: Trexan, Salazopyrin, Oxiklorin, Prednison, Remicademethotrexate 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 + infliximab |
| Trexan+Salazopyrin+Oxiklorin+prednisolone + placeboAlso: Trexan, Salazopyrin, Oxiklorin, Prednison, 0.9% NaClmethotrexate 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 | Drug | Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo |
Primary outcome
Remission by ACR criteria
Time frame: 2 years
3 secondary outcomes
Radiology (erosions)
Time frame: 2 years
Sustained remission
Time frame: 2 years
Costs
Time frame: 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Results publication: PubMed 22753402Leirisalo-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.
- Results publication: PubMed 25274892Rantalaiho 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.
- Results publication: PubMed 23908187Rantalaiho 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.
- Derived from this study: PubMed 40548492Sandstrom 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.
- Derived from this study: PubMed 34263700Vuolteenaho 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.
- Derived from this study: PubMed 31732558Sandstrom 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.
- Derived from this study: PubMed 30295425Rantalaiho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjatta Leirisalo-Repo, MD, Prof study director
University of Helsinki
Timo Möttönen, MD, Prof study chair
University of Turku
Markku Korpela, MD, PhD study chair
Tampere University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab in people with Rheumatoid Arthritis, run by University of Helsinki at 13 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission by ACR criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908089, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.