Spondyloarthritis
Conditions
Interventions
Product Name: Humira
Product Code: Adalimumab
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use
Sponsors
Hvidovre Hospital, Dept. of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of spondyloarthritis according to ESSG criteria according to the European Spondyloarthritis Study Group (ESSG) criteria (Dougados et al, Arthritis Rheum 1991; 34: 1218-27) 2. Clinical active disease, defined as a BASDAI score > 4 despite concurrent NSAID therapy. 3. Presence of sacroiliitis on conventional radiography or MRI. 4. Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists. 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. Previous anti-TNFa-therapy 2. Treatment with disease modyfying anti-rheumatic drugs within 4 weeks before screening 3. Oral, intraarticular or intramuscular glucocorticoid within 4 before screening. 4. Pregnancy and lactation. 5. HIV, Hepatitis B or C, tuberculosis, other infections. 6. Malignancies 7. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease (including demyelinating disease) 8. Contraindications to anti-TNFa-therapy 9. Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identification of candidate imaging- and bio- markers for improved assessment of disease activity and progression in spondyloarthritis patients receiving adalimumab.;Secondary Objective: Identification of candidate imaging- and bio- markers for improved prediction of therapeutic response in spondyloarthritis patients receiving adalimumab Investigation of the effect (as measured by conventional (incl. ASAS20 response rate) and experimental methods) of adalimumab in patients with spondyloarthritis, at week 12 by comparision with the effect of placebo, and at week 24 by determining the proportion of responders. Investigation of the effect (as measured by conventional and experimental methods) of adalimumab in the patient subgroup with MRI-determined sacroiliitis without the radiographic damage required by the New York criteria for ankylosing spondylitis. ;Primary end point(s): ASAS50% response at week 24 | — |
Countries
Denmark
Outcome results
None listed