Rheumatoid arthritis (RA) MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
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Sponsors
Diakonhjemmet Hospital AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria (48), Appendix 2. b) Male or non-pregnant, non-nursing female c) >18 years of age and =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: a) Abnormal renal function, defined as serum creatinine > 142 µmol/L in female and > 168 µmol/L in male, or a GFR 3 x upper normal limit), active or recent hepatitis, cirrhosis c) Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases d) Leukopenia and/or thrombocytopenia e) Inadequate birth control, pregnancy, and/or breastfeeding f) Indications of active TB g) Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients in sustained remission.;Secondary Objective: a) To study predictors of successful DMARD reduction and discontinuation in RA remission b) To assess the effect of half dose synthetic DMARDs on disease activity in RA patients in sustained remission c) To evaluate the cost-effectiveness of alternative treatment strategies in stable RA remission d) To assess whether the choice of DMARD strategy in RA remission influences the level of Magnetic Resonance Imaging (MRI) and ultrasonography detected inflammation e) To assess joint damage in patients in sustained RA remission who continue to receive stable DMARD treatment and patients who receive reduced DMARD treatment f) To provide long-term follow-up data on patients included in the original ARCTIC study g) To assess relationships between treatment, inflammation, physical function and joint damage in RA remission h) To examine adverse events rates in different DMARD strategies in RA remission ;Primary end point(s): The primary endpoint is the proportion of patients who are non-failures at 12 months, i.e. have not experienced a flare during this time period. A flare is defined as an increase in DAS to >1.6 with a change in DAS of = 0.6 and more than one swollen joint based on examination of 44 joints (see Appendix 4 for description of joint examination). If a patient does not fulfill this formal definition, but experiences a clinically significant flare according to the investigator and patient, this should be treated as a flare but recorded separately in the CRF.;Timepoint(s) of evaluation of this end point: 12 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients in DAS (i.e. DAS < 1.6), DAS28 (i.e. DAS28 < 2.6), CDAI (i.e. = 3.3), SDAI (SDAI= 2.8), 2011 ACR/EULAR remission and other relevant remission criteria during the first, second, third and total study period. • Time from randomization to first flare during the total study period • Time in remission according to the DAS, DAS28, CDAI, SDAI and ACR/EULAR binary remission criteria during the total study period. • Disease activity (status and change scores) according to DAS28, DAS, CDAI, SDAI at relevant time points during the first, second, third and total study period. • MRI scores (RAMRIS, joint space narrowing, tenosynovitis – status and change scores) during the first, second, third and total study period. • Ultrasound scores (grey scale synovitis, power doppler signal – status and change scores) during the first, second, third and total study period. • Change in radiographic score (modified Sharp van der Heijde (vdHSS) during the first, second, third and total study period. • Proportion of patients with progression of radiologic joint damage (e.g..annual increase in van der Heijde modified Sharp score = 1 unit, annual increase in RAMRIS erosion score = 1 unit) during the first, second, third and total study period. • SF-36 (physical and mental composite scores), HAQ, RAID, SF-6D and EQ-5D scores (change and status) during the first, second, third and total study period. • Direct and indirect costs related to RA and the treatment of RA, measured during the first, second, third and total study period Exploratory/secondary endpoints will not be limited to those mentioned above, and will include endpoints as necessary to explore the secondary objectives of the study. ;Timepoint(s) of evaluation of this end point: 4, 8, 12, 16, 20, 24, 28, 32, 36 months after randomization. Time to event endpoints will be evaluated continuously during until 36 months after randomization | — |
Countries
Norway
Contacts
Public ContactPrincipal Investigator
Diakonhjemmet Hospital AS
Outcome results
None listed