Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Dermatomyositis (Connective Tissue Disease)
Treatment
Therapeutic drug monitoring (TDM) of adalimumab
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A clinical diagnosis of RA
≥ 18 and under 75 years of age at screening
On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3months and a maximum of 24 months
In low disease activity or remission (DAS28-CRP under 3.2) and indication forcontinuation of treatment according to the treating physician
Subject capable of understanding and signing an informed consent form
Exclusion
Exclusion Criteria:
Major comorbidities, such as previous malignancies within the last 5 years,uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollablehypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratorydiseases, demyelinating disease, significant chronic widespread pain syndrome,significant renal or hepatic disease, and/or other diseases or conditions whicheither contraindicate treatment with SC TNFi or make adherence to the protocoldifficult
Hypersensitivity to sc TNFi (adalimumab).
Pregnancy, or subject considering becoming pregnant during the study period
Psychiatric or mental disorders, alcohol abuse or other substance abuse, languagebarriers, or other factors that makes adherence to the study protocol difficult
Changes in csDMARD co-medication, including dose changes of csDMARD or changes inthe dose of corticosteroids within the last 2 months
Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excludingcsDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
Active participation in any other interventional study.
In need of live vaccines during the study period.
Study Design
Study Description
Connect with a study center
Medical University Vienna
Vienna, A-1090
AustriaActive - Recruiting
Diakonhjemmet sykehus
Oslo, N-0319 0319
NorwayActive - Recruiting
Haukeland University Hospital
Bergen, 5009
NorwayActive - Recruiting
Nordland Hospital Trust
Bodø, 8005
NorwayActive - Recruiting
Drammen Hospital
Drammen, 3004
NorwayActive - Recruiting
Førde Hospital Trust
Førde, 6812
NorwayActive - Recruiting
Haugesund Rheumatism Hospital
Haugesund, 5528
NorwayActive - Recruiting
Hospital of Southern Norway Trust
Kristiansand, 4615
NorwayActive - Recruiting
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, 2609
NorwayActive - Recruiting
Helgeland Hospital Trust
Mo I Rana, 8613
NorwayActive - Recruiting
Østfold Hospital Trust
Moss, 1535
NorwayActive - Recruiting
Martina Hansen's Hospital
Sandvika,
NorwayActive - Recruiting
Betanien Hospital
Skien, 3722
NorwayActive - Recruiting
Stavanger University Hospital
Stavanger, 4019
NorwayActive - Recruiting
University Hospital of North Norway
Tromsø, 9019
NorwayActive - Recruiting
St.Olavs Hospital
Trondheim, 7030
NorwayActive - Recruiting
Ålesund Hospital
Ålesund, 6017
NorwayActive - Recruiting
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest,
RomaniaActive - Recruiting
Sahlgrenska Universitetssjukehuset
Gothenburg, 41345
SwedenActive - Recruiting
Karolinska University Hospital
Stockholm, 141 86
SwedenActive - Recruiting
Queen Mary
London, Sw15 5pn SW15 5PN
United KingdomSite Not Available
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