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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726804
Recruitment Status : Terminated (It was not possible to recruit patients)
First Posted : August 1, 2008
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
MOstergaard, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors [ Time Frame: 40 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00726804

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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
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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
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Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen Identifier: NCT00726804    
Other Study ID Numbers: SPARTA
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors