Spondyloarthropaties and ankylosing spondyllitis
Conditions
Interventions
Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277313
Concentration unit: mg/kg milligram(s)/kilogram
Concentrat
Sponsors
Department of Rheumatology, Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 12 months of treatment with a) adalimumab 40 mg subcutaneously every other week, or b) subcutneous injection of Etanercept 25 mg twice weekly or Etanercept 50 mg once a week or c) infusion of Infliximab 3 mg/kg or 5 mg/kg every 6 to 8 week 2. Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria (Dougados et al, Arthritis Rheum 1991; 34: 1218-27) or ankylosing spondylitis according to the modified New York Criteria 3. No clinical active disease, defined as a BASDAI score 18 years, able to give informed consent, no contraindications for anti-TNFa-therapy 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
Exclusion criteria: 1. Treatment with disease modifying anti-rheumatic drugs (DMARDs) are accepted during the study, but no changes in the dose is allowed. 2. Oral, intraarticular, intramuscular or intravenous glukokorticoid within 4 weeks before screening 3. Pregnancy or lactation - patients who wants to get pregnant (male or female) can take part in the first 6 months of the study, because they have to use sufficient contraceptives in 6 moths after withdrawal of TNF-alpha inhibitors 4. HIV, hepatitis B or C, tuberculosis, other infections 5. Malignancies 6. Other serious concomitant diseases (uncontrolled/severekidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease) 7. Contraindications to anti-TNFa-therapy 8. Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of discontinuation of TNF-alpha inhibitor therapy in patients with spondyloarthritis (SpA) with low disease activity after at least 1 year of treatment with respect to clinical disease flare (as assessed by Kaplan-Meier statistics). To investigate the efficacy of TNF-alpha inhibitor when re-starting therapy because of disease flare in the above mentioned patient population.;Secondary Objective: To investigate the effect of discontinuation of TNF-alpha inhibitor therapy with respect to disease flare as assessed by MRI (as measured by Kaplan-Meier statistics) To investigate the effect (as measured by conventional and experimental imaging and laboratory methods) of discontinuation of TNF-alpha inhibitor. To identify candidate imaging- and bio- markers for prediction of flare in SpA patients discontinuing TNF-alpha inhibitor. To identify candidate imaging- and bio- markers for improved assessment of disease activity and progression in SpA patients discontinuing and eventually re-starting TNF-alpha inhibitor. ;Primary end point(s): The primary endpoint is disease flare defined as a change in BASDAI of 2 points (or 20 mm on a VAS scale). For patients with disease flare re-starting adalimumab there is a secondary endpoint: ASAS50% response at week 24. | — |
Countries
Denmark
Outcome results
None listed