EUCTR2009-014394-41-DKActive, not recruitingPhase 1
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Hvidovre Hospital
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Alder >18 år og <85 år
- •2.RA i henhold til American College of Rheumatologys 1987-kriterier
- •3.Moderat eller svær aktiv RA defineret som DAS28 større end 3,2 (CRP-baseret)
- •4.Klinisk indikation for TNF-a inhibitor behandling ved den behandlende læge
- •5.Ingen tidligere TNF-a inhibitor behandling
- •6.Ingen kontraindikationer for TNF-a inhibitor behandling (se afsnit 10.1.1)
- •7.Ingen kontraindikationer for MRI (se bilag C).
- •8.Serum/plasma kreatinin i normalområdet
- •9.Sufficient anti-konception for fertile kvinder (se afsnit 7.2.1)
- •10.I stand til at afgive informeret samtykke
- •11.I stand til at følge protokollens undersøgelsesprogram
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Andre DMARDs end MTX fra ?4 uger før inklusion og i hele studieperiode
- •2.Cyclophosphamid, klorambucil eller andre alkylerende stoffer fra ?4 uger før inklusion og i hele studieperioden
- •3.Intramuskulær eller intravenøs injektion af glucocorticoid fra ?4 uger før inklusion og i hele studieperioden
- •4.Graviditetsønske, graviditet eller amning
- •5.Kontraindikationer mod behandling med TNF-? inhibitor (se afsnit 10.1.1)
- •6.Kontraindikationer mod MRI (se bilag C).
- •7.Kendt nyligt medicin eller alkoholmisbrug
- •8.Manglende skriftligt samtykke
- •9.Manglende evne til at gennemføre undersøgelsesprogrammet af fysiske eller psykiske årsager
Investigators
Similar Trials
Completed
Not Applicable
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating BiomarkersRheumatoid ArthritisNCT01029613Glostrup University Hospital, Copenhagen40
Active, not recruiting
Phase 1
Adalimumab dose optimization in rheumatoid arthritis using drugconcentration in blood (ADDORA): multi-center open label randomizedcontrolled trailRheumatoid arthritisEUCTR2019-001554-25-NLReade267
Recruiting
Not Applicable
Adalimumab dose optimisation in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-centre open label randomised controlled trailrheumatoid arthritisNL-OMON47985Jan van Breemen Instituut267
Completed
Not Applicable
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in TaiwanRheumatoid ArthritisNCT02616380AbbVie100
Recruiting
Not Applicable
Adalimumab drug optimisation in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-centre open label randomised controlled trailRheumatoid arthritisNL-OMON26185Reade Rheumatology Research Institute267