Rheumatoid Arthritis
Conditions
Brief summary
This is an international (Nordic) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare two alternative de-escalation strategies in patients who achieved low disease activity during first-line therapy in the NORD-STAR study.
Detailed description
25 patients have been included in the study of which 1 has had an early termination an 22 have completed the full study.
Interventions
DRUGSulphasalazine + Hydroxychloroquine OR Prednisolone
Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, and Iceland)
BIOLOGICALCimzia
Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
BIOLOGICALOrencia
Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
BIOLOGICALRoActemra
Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has been enrolled in the NORD-STAR study according to that study inclusion criteria (and did not meet any of the
Exclusion criteria
in that study). 2. Subject has low-disease-activity according to: 2.8 \< CDAI ≤ 10.0, from week 56 in the NORD-STAR study, i.e. during 24 weeks before randomization. 3. Subject has not more than 3 tender out of the 28 joints. 4. According to the investigators opinion the remaining findings are not due to significant active disease (RA). 5. Female subject is either not of childbearing potential (postmenopausal, surgically sterile etc.), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion: * Intrauterine device (IUD) * Contraceptives (oral, parenteral, patch) for three months prior to study drug administration) * A vasectomized partner 6. Subject is judged to be in good general health as determined by the principal investigator. 7. Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients maintaining low disease activity after dose reduction | 24 weeks after dose reduction | The proportion of patients, with early dose reduction vs late dose reduction, who maintain low disease activity (2.8 \< CDAI ≤ 10.0) at the time point 24 weeks after the dose was first reduced. |
Countries
Sweden
Outcome results
None listed