Know Cancer

or
forgot password

Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares


Phase 4
18 Years
80 Years
Open (Enrolling)
Both
SPONDYLOARTHRITIS

Thank you

Trial Information

Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors

Outcome Time Frame:

40 weeks

Safety Issue:

No

Principal Investigator

Mikkel Ƙstergaard, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Department of rheumatology, Glostrup Hospital, Copenhagen

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

SPARTA

NCT ID:

NCT00726804

Start Date:

March 2008

Completion Date:

December 2012

Related Keywords:

  • SPONDYLOARTHRITIS
  • Spondylarthritis

Name

Location