This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3 phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open three arm treatment phase for each patient, followed by a 5-year observational phase for all patients still in remission.
Rheumatoid Arthritis (RA) is characterized by progressive synovitis leading to degradation of articular cartilage leading to erosions in juxtaarticular bones driven by auto antibodies. Few clinical studies could show that quick and thorough control of inflammatory processes could stop degradation processes \[17, 18, 19, 20, 21\] and had presumably better prognosis of remission than untreated and/or uncontrolled RA disease \[20\]. These studies aimed at low disease activity \[20\], often focused on early RA \[18, 19\], evaluating different therapy strategies, mostly escalating instead of deescalating medications \[20, 21\]. Real "RA- in - remission" or therapy reduction studies are missing up to now, even if first small trials focusing on one preparation showed promising results \[16, 17\]. In this study all conventional medications in usual combinations are being evaluated for the treatment of Rheumatoid Arthritis in different stages of disease duration. The study is scheduled as a 365-day (12-months), phase 3 multicenter, randomized, open, prospective, controlled, parallel-group intervention study in 318 patients with Rheumatoid Arthritis. Based on the results of the clinical studies mentioned above, and the need for a guideline with therapy proposals for RA- patients in remission all current preparations will be evaluated in subjects under the controlled setting of a clinical study. The information obtained from this study will assess the formulation of new guidelines regarding patients with Rheumatoid Arthritis in remission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
Stable dosage of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)
Dose reduction of 50% for 12 months of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)
Asklepios Klinikum Bad Abbach
Bad Abbach, Germany
RECRUITINGRheumapraxis Manger
Bamberg, Germany
RECRUITINGProportion of subjects in each treatment group who are still in remission after 12 months (remission defined as DAS 28 < 2.6) reduction or even discontinuation in RA-patients after achievement of long lasting remission.
Time frame: 12 months
Proportion of subjects in each treatment group who are still in remission after 3, 6, 9 months (remission defined as DAS 28 < 2.6).
Time frame: 12 months
Proportion of subjects in each treatment group who are still in remission after 3, 6, 9 months (remission defined according to Pinals - criteria)
Time frame: 12months
Proportion of subjects in each treatment group with increased disease activity
Time frame: 12 months
Proportion of adverse events (to be documented via "unscheduled visit"-sheet)
Time frame: 12 months
DAS 28 after 3, 6, 9 and 12 months
Time frame: 12 months
CRP after 3, 6, 9 and 12 months
Time frame: 12 months
ESR after 3, 6, 9 and 12 months
Time frame: 12 months
Swollen joint counts after 3, 6, 9 and 12 months
Time frame: 12 months
Tender joint counts after 3, 6, 9 and 12 months
Time frame: 12 months
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Dose reduction of 50% of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®) for 6 months and if they are still in remission therapy will be discontinued.
Rheumapraxis Bayreuth
Bayreuth, Germany
RECRUITINGSchlosspark-Klinik
Berlin, Germany
RECRUITINGSchwerpunktpraxis für Rheumatologie Burghausen
Burghausen, Germany
RECRUITINGPGRN.de Praxisgemeinschaft Rheumatologie Nephrologie
Erlangen, Germany
RECRUITINGUniversitätsklinikum Heidelberg; Medizinische Klinik V
Heidelberg, Germany
RECRUITINGGemeinschaftspraxis Dres. Demary und von Hinüber
Hildesheim, Germany
RECRUITINGPraxiszentrum St. Bonifatius
München, Germany
RECRUITINGPraxis Professor Nüsslein
Nuremberg, Germany
RECRUITING...and 2 more locations
Patient self assessment of pain (VAS) after 3, 6, 9 and 12 months
Time frame: 12 months
Physician's and patient's assessment of global disease activity (VAS) after 3, 6, 9 and 12 months
Time frame: 12 months
Duration of joint stiffness after 3, 6, 9 and 12 months
Time frame: 12 months
HAQ (Health Assessment Questionnaire) after 3, 6, 9 and 12 months
Time frame: 12 months
SF-36 (Short Form) Score after 3, 6, 9 and 12 months
Time frame: 12 months
Coping-Questionnaire after 3, 6, 9 and 12 months
Time frame: 12 months
PASS (patient acceptable symptom state) after 3, 6, 9 and 12 months
Time frame: 12 months
WPAI:RA (Work Productivity and Activity Impairment Questionnaire) after 3, 6, 9, 12 months
Time frame: 12 months
BDI - II (Beck-Depression Inventory) after 3, 6, 9 and 12 months
Time frame: 12 months
Flare Questionnaire RA (German version): At time of potential flare
Time frame: 12 months