SPONDYLOARTHRITIS
Conditions
Brief summary
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in SpA patients without immediate relapse of disease activity. Two studies have investigated discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. The effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of TNF-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the New York criteria.
Interventions
DRUGDiscontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)
Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow.
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. At least 12 months of treatment with infliximab, etanercept and adalimumab. 2. Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria 3. No clinical active disease, defined as a BASDAI score \< 4. 4. Among other issues: Age \>18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy
Exclusion criteria
1. Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening 2. Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening 3. Pregnancy or lactation 4. HIV, hepatitis B or C, tuberculosis, other infections 5. Malignancies 6. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease) 7. Contraindications to anti-TNF-alpha-therapy 8. Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors | 40 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Bath ankylosing spondylitis disaease activity score, Bath ankylosing spondylitis functional index, Bath ankylosing spondylitis metrology index, C-Reactive protein, MRI, biomarkers of inflammation, cartilage and bone turnover | 40 weeks |
Countries
Denmark
Outcome results
None listed