Status:
UNKNOWN
Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Moderate to Severe Active Axial Spondyloarthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of les...
Detailed Description
Randomized controlled study with two treatment arms (Phase II), 1 year open extension Efficacy - To assess efficacy of etanercept vs. sulfasalazine when added to NSAIDs in patients with moderate to s...
Eligibility Criteria
Inclusion
- Patients 18 - 50 years of age who have moderate to severe active axial spondyloarthritis.
- Diagnosis made by :Chronic low back pain (duration \> 3 months, onset \< 45 years of age)plus 3 out of the 6 following criteria if imaging is positive or 4 out of the following 6 criteria if imaging is negative ·
- Inflammatory back pain:
- Good or very good response to NSAIDs
- One or more of the following extraspinal manifestations: uveitis, peripheral arthritis, enthesitis, HLA-B27 positive
- Positive imaging: MRI showing acute inflammatory lesions in spine or SIJ (in the past) or bilateral sacroiliitis grade 2-4 or unilateral sacroiliitis grade 3-4 in x-ray not older than 12 months
- Positive family history for SpA
- MRI at screening showing acute inflammatory lesions in SIJ or spine
- Active disease is defined as:
- a BASDAI score of \>=4
- back pain score (BASDAI question 2) of \>= 4 despite concurrent NSAID therapy, or intolerance to NSAIDs.
- Other inclusion criteria include, if on prednisone:
- \<7.5 mg per day
- stable for 4 weeks prior to baseline
- Women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception for a duration of 6 months after stop of etanercept therapy. Sexual active men must use an accepted method of contraception for a duration of 6 months after stop of etanercept therapy.
- Reading a normal chest/lung x-ray which should have been performed within the last 12 weeks before inclusion
- Able to self-administer injectable drug supplies or have a caregiver who will do so.
- Able to store injectable test article at 2° to 8° C.
Exclusion
- Disease duration of longer than 5 years
- History of active tuberculosis (TB), histoplasmosis or listeriosis.
- History of positive HIV status, known hepatitis B or C
- History of malignancy other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma.
- Antibiotic treatment within 3 weeks prior to screening.
- Previous treatment with TNF-alpha blockers
- Treatment with sulasalazine in the last 6 months before participation in the clinical trial
- severe internal medical diseases such as severe cardiac, hepatic, gastrointestinal, neurological, psychiatric diseases
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00844142
Start Date
November 1 2005
End Date
July 1 2013
Last Update
February 13 2009
Active Locations (9)
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1
Charité Campus Mitte, Rheumatology
Berlin, Germany, 10117
2
Praxis Mielke
Berlin, Germany, 12627
3
Praxis Zinke
Berlin, Germany, 13055
4
Klinikum Buch
Berlin, Germany, 13125