Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis

Phase 4

Terminated

• Conditions: SPONDYLOARTHRITIS
• Interventions: Drug: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)

• Registration Number: NCT00726804
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)	-

Primary Outcome Measures

Name	Time	Method
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors	40 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Glostrup Hospital; 🇩🇰 Copenhagen, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark

Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Gråsten Gigthospital; 🇩🇰 Gråsten, Denmark