Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Treatment adalimumab 40 mg sc every other week
Phase phase 2/phase 3
Sponsor Charite University, Berlin, Germany
Collaborator Abbott
Start date March 2005
End date June 2007
Trial size 46 participants
Trial identifier NCT00235105, A01, N.A.

Summary

Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.

Study Objectives:Efficacy –To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety – To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
ASAS 40 at week 12
time frame:

Secondary Outcomes

Measure
ASAS 20, 70·
time frame:
BASDAI 20, 50, 70
time frame:
BASFI (absolute change from Baseline)
time frame:
Mobility examinations: BASMI, Chest Wall Expansion
time frame:
DC-ART20 (5 out of 6)
time frame:
CRP, ESR
time frame:
Quality of Life: SF-36
time frame:
Numeric Rating Scale (NRS) – physicians global, patients global, general pain, nocturnal pain
time frame:
Enthesitis index (Maastricht scale)
time frame:
swollen joint count
time frame:
EQ-5D
time frame:
Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

  • Inflammatory back pain1
  • Good or very good response to NSAIDs
  • One or more of the following extraspinal manifestations: uveitis, peripheral arthritis, enthesitis
  • HLA-B27 positive
  • Positive MRI showing acute inflammatory lesions in spine or ISG
  • Positive family history for SpA Active disease is defined as a BASDAI score of equal or more than 4, back pain score (BASDAI question 2) of equal or more than 4 despite concurrent NSAID therapy, or intolerance to NSAIDs. Other inclusion criteria include: If on prednisone, equal or less than 7.5 mg per day; stable for 4 weeks prior to baseline. An evaluation for latent tuberculosis infection will be performed using a Mendel Mantoux Test with 10TE (PPD), reading a chest x-ray, which should have been performed within the last 12 weeks before inclusion, and history of exposure to infected subjects. Patients who have evidence of latent TB infection should be given prophylaxis in accordance with local guidelines (Isoniazid 300 mg with adequate substitution of vitamin B6 for 9 months or 600 mg Rifampicine for 6 months). The prophylaxis will start 4 weeks before adalimumab is administered. After 2 weeks of prophylaxis blood tests (liver enzymes, creatinine and blood count) will be obtained. Patients with documented prophylaxis in the past need not to repeat this treatment. Women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate method of contraception (including 3 months after study completion). Sexual active men must use an accepted method of contraception including 3 months after study completion. 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

    Additional Information

    Official title Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase
    Principal investigator Joachim Sieper, Prof.
    Description The study is a two center 12-week double-blind, placebo-controlled trial of adalimumab in patients with moderate to severely active axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to who are or intolerant to NSAID therapy. Patients may have been treated in the past with concomitant DMARDs. For these patients a washout period of at least 4 weeks is necessary. If Leflunomide was discontinued, it should be stopped at least 3 months or should be washed out within 4 weeks before study start. Patients who have been treated previously with approved biologics are allowed to enter the study if they failed due to lack of efficacy and/or intolerance. The placebo-controlled treatment period of 12 weeks will be followed by an open-label maintenance therapy up to Week 52. Following screening and baseline evaluations, patients will be assessed at Weeks 2, 4, 8, and 12. During the maintenance therapy visits will be performed at Weeks 16, 20 and every eight weeks thereafter.Efficacy and safety measurements will be recorded throughout the entire 52 weeks study.Non-responders (fail to reach ASAS 40) at and after week 12 of open label therapy (at week 24), will be eligible for adalimumab dose escalation to 40 mg weekly.The study will be followed by a 24 weeks follow up phase. During this period the patients will be assessed every eight weeks.
    Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
    Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.