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

This study has been terminated.
(It was not possible to recruit patients)
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
First received: July 30, 2008
Last updated: August 18, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Drug: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares

Resource links provided by NLM:

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: March 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2 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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00726804

Glostrup Hospital
Copenhagen, Denmark, 2600
Glostrup Hospital
Copenhagen, Denmark, 2650
Gentofte Hospital
Copenhagen, Denmark, 2730
Gentofte Hospital
Copenhagen, Denmark, 2900
Gråsten Gigthospital
Gråsten, Denmark
Vejle Sygehus
Vejle, Denmark
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
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
  More Information

Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00726804     History of Changes
Other Study ID Numbers: SPARTA 
Study First Received: July 30, 2008
Last Updated: August 18, 2015
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2016