Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis

SPONDYLOARTHRITIS Clinical Trial

— SPARTA  

Official title:

Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726804
• Other study ID #: SPARTA
• Status: Terminated
• Phase: Phase 4
• First received: July 30, 2008
• Last updated: August 18, 2015
• Start date: March 2008
• Est. completion date: May 2012

Study information

• Verified date: August 2015
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylarthritis
• SPONDYLOARTHRITIS

Intervention

Drug:
• Discontinuation 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.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen
Denmark	Gentofte Hospital	Copenhagen
Denmark	Glostrup Hospital	Copenhagen
Denmark	Glostrup Hospital	Copenhagen
Denmark	Gråsten Gigthospital	Gråsten
Denmark	Vejle Sygehus	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors		40 weeks	No
Secondary	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	No