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Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00844142
First received: February 12, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose
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 less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.

Condition Intervention Phase
Moderate to Severe Active Axial Spondyloarthritis
Drug: Etanercept 25mg
Drug: Sulfasalazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled 12 Months Trial With Etanercept (Enbrel ®) vs. Sulfasalazine in Early Axial Spondyloarthritis With Focus on Improvement of Acute Inflammatory Lesions as Detected by MRI. Amendment 4: 1-Year Extension of Study

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Primary outcome: Reduction of active inflammatory lesions in MRI at 12 months. [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome: ASAS 20%, 40%, 70% response, ASAS criteria for partial remission· BASDAI 20%, 50%, 70% improvement · BASFI · [ Time Frame: 108 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2005
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
etanercept 25mg twice weekly
Drug: Etanercept 25mg
patients will receive etanercept 25mg twice weekly
Active Comparator: 2
Sulfasalazine 2000- 3000mg daily
Drug: Sulfasalazine
in this arm patients will receive sulfasalazine 2000- 3000mg per os daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT00844142

Locations
Germany
Charité Campus Mitte, Rheumatology
Berlin, Germany, 10117
Praxis Mielke
Berlin, Germany, 12627
Praxis Zinke
Berlin, Germany, 13055
Klinikum Buch
Berlin, Germany, 13125
Waldkrankenhaus
Berlin, Germany, 13589
Schlossparkklinik, Rheumatology
Berlin, Germany, 14059
Immanuel Krankenhaus
Berlin, Germany, 14109
Praxis Klopsch
Neubrandenburg, Germany, 17033
Praxis Bohl-Bühler
Potsdam, Germany, 14469
Sponsors and Collaborators
Charite University, Berlin, Germany
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Joachim Sieper, MD Charite, Campus Benjamin-Franklin, Rheumatology, Berlin, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Joachim Sieper, Charité Rheumatology Campus Benjamin-Franklin
ClinicalTrials.gov Identifier: NCT00844142     History of Changes
Other Study ID Numbers: M01  Enbrel-Sulfa-Early-AS 
Study First Received: February 12, 2009
Last Updated: February 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
ankylosing spondylitis
axial spondyloarthritis
magnetic resonance imaging
etanercept
sulfasalazine

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Etanercept
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 09, 2016