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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
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
  Purpose

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
SPONDYLOARTHRITIS
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 ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726804

Contacts
Contact: Mikkel Østergaard, Professor +4521603865 mo@dadlnet.dk
Contact: Susanne J Pedersen, MD +4541431326 susanne_juhl_ped@dadlnet.dk

Locations
Denmark
Gentofte Hospital Recruiting
Copenhagen, Denmark, 2730
Contact: Michael S Hansen, MD, PhD         
Sub-Investigator: Michael S Hansen, Md, PhD         
Glostrup Hospital Recruiting
Copenhagen, Denmark, 2650
Contact: Inge J Sørensen, MD, PhD    004538633014      
Sub-Investigator: Inge J Sørensen, MD, PhD         
Gentofte Hospital Not yet recruiting
Copenhagen, Denmark, 2900
Contact: Ole R Madsen, MD, MSci         
Sub-Investigator: Ole R Madsen, MD, PhD; MSci         
Glostrup Hospital Recruiting
Copenhagen, Denmark, 2600
Contact: Gorm Thamsborg, MD, MSci         
Sub-Investigator: Gorm Thamsborg, MD, MSci         
Gråsten Gigthospital Suspended
Gråsten, Denmark
Vejle Sygehus Suspended
Vejle, Denmark
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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

No publications provided

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: March 27, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
TNFR-Fc fusion protein
Adalimumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014