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:
Glostrup University Hospital, Copenhagen
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
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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:
- At least 12 months of treatment with infliximab, etanercept and adalimumab.
- Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria
- No clinical active disease, defined as a BASDAI score < 4.
- Among other issues: Age >18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy
Exclusion Criteria:
- Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- Pregnancy or lactation
- HIV, hepatitis B or C, tuberculosis, other infections
- Malignancies
- Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- Contraindications to anti-TNF-alpha-therapy
- Contraindications to MRI
Contacts and Locations
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 May 19, 2013