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Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis (SPARTA)

This study is currently recruiting participants.
Verified March 2012 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00726804
First received: July 30, 2008
Last updated: March 27, 2012
Last verified: March 2012
History of Changes

July 30, 2008
March 27, 2012
March 2008
December 2012   (final data collection date for primary outcome measure)
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726804 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
BASDAI, BASFI, BASMI, CRP, MRI, biomarkers of inflammation, cartilage and bone turnover [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis
Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
SPONDYLOARTHRITIS
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.
2
Intervention: Drug: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Mikkel Østergaard, Professor +4521603865 mo@dadlnet.dk
Contact: Susanne J Pedersen, MD +4541431326 susanne_juhl_ped@dadlnet.dk
Denmark
 
NCT00726804
SPARTA
Yes
MOstergaard, Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
Not Provided
Study Chair: Mikkel Østergaard, Professor Department of rheumatology, Glostrup Hospital, Copenhagen
Study Chair: Susanne J Pedersen, MD Department of rheumatology, Glostrup Hospital, Copenhagen
Study Chair: Inge J Sørensen, MD, PhD Department of rheumatology, Glostrup Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP