Phase
Condition
Arthritis And Arthritic Pain
Rheumatoid Arthritis
Joint Injuries
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
AustriaSite Not Available
Medical University Vienna
Vienna 2761369, A-1090
AustriaActive - Recruiting
Humanitas Research Hospital
Milan 3173435,
ItalySite Not Available
Diakonhjemmet sykehus
Oslo, N-0319 0319
NorwaySite Not Available
Diakonhjemmet sykehus
Oslo 3143244, N-0319 0319
NorwayActive - Recruiting
Haukeland University Hospital
Bergen, 5009
NorwaySite Not Available
Haukeland University Hospital
Bergen 3161732, 5009
NorwayActive - Recruiting
Nordland Hospital Trust
Bodø, 8005
NorwaySite Not Available
Nordland Hospital Trust
Bodø 3160881, 8005
NorwayActive - Recruiting
Drammen Hospital
Drammen, 3004
NorwaySite Not Available
Drammen Hospital
Drammen 3159016, 3004
NorwayActive - Recruiting
Førde Hospital Trust
Førde, 6812
NorwaySite Not Available
Førde Hospital Trust
Førde 3156804, 6812
NorwayActive - Recruiting
Haugesund Rheumatism Hospital
Haugesund, 5528
NorwaySite Not Available
Haugesund Rheumatism Hospital
Haugesund 3153623, 5528
NorwayActive - Recruiting
Hospital of Southern Norway Trust
Kristiansand, 4615
NorwaySite Not Available
Hospital of Southern Norway Trust
Kristiansand 3149318, 4615
NorwayActive - Recruiting
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, 2609
NorwaySite Not Available
Lillehammer Hospital for Rheumatic Diseases
Lillehammer 3147474, 2609
NorwayActive - Recruiting
Helgeland Hospital Trust
Mo I Rana, 8613
NorwaySite Not Available
Helgeland Hospital Trust
Mo i Rana 3145614, 8613
NorwayActive - Recruiting
Østfold Hospital Trust
Moss, 1535
NorwaySite Not Available
Østfold Hospital Trust
Moss 3145375, 1535
NorwayActive - Recruiting
Martina Hansen's Hospital
Sandvika,
NorwaySite Not Available
Martina Hansen's Hospital
Sandvika 3140112,
NorwayActive - Recruiting
Betanien Hospital
Skien, 3722
NorwaySite Not Available
Betanien Hospital
Skien 3139075, 3722
NorwayActive - Recruiting
Stavanger University Hospital
Stavanger, 4019
NorwaySite Not Available
Stavanger University Hospital
Stavanger 3137115, 4019
NorwayActive - Recruiting
University Hospital of North Norway
Tromsø, 9019
NorwaySite Not Available
University Hospital of North Norway
Tromsø 3133895, 9019
NorwayActive - Recruiting
St.Olavs Hospital
Trondheim, 7030
NorwaySite Not Available
St.Olavs Hospital
Trondheim 3133880, 7030
NorwayActive - Recruiting
Ålesund Hospital
Ålesund, 6017
NorwaySite Not Available
Ålesund Hospital
Ålesund 3163392, 6017
NorwayActive - Recruiting
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest,
RomaniaSite Not Available
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest 683506,
RomaniaActive - Recruiting
Sahlgrenska Universitetssjukehuset
Gothenburg, 41345
SwedenSite Not Available
Sahlgrenska Universitetssjukehuset
Gothenburg 2711537, 41345
SwedenActive - Recruiting
Karolinska University Hospital
Stockholm, 141 86
SwedenSite Not Available
Karolinska University Hospital
Stockholm 2673730, 141 86
SwedenActive - Recruiting
Queen Mary
London 2643743, SW15 5PN SW15 5PN
United KingdomActive - Recruiting
Queen Mary
London, Sw15 5pn SW15 5PN
United KingdomSite Not Available

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