D2E7-Early AS

NCT00235105 | Unknown Phase 2

• 1 other identifier: A01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

early ankylosing spondylitis; spondyloarthritis; trial; adalimumab

Outcome Measures

Primary Outcomes (1)

• ASAS 40 at week 12

Secondary Outcomes (12)

• ASAS 20, 70·

• BASDAI 20, 50, 70

• BASFI (absolute change from Baseline)

• Mobility examinations: BASMI, Chest Wall Expansion

• DC-ART20 (5 out of 6)

Interventions

Adalimumab 40 mg sc every other week DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older who have moderate to severely active axial spondyloarthritis.
• Diagnosis made by:Chronic low back pain (duration \> 3 months, onset \< 50 years of age)plus 3 out of the 6 following criteria (including two of the following three criteria: inflammatory back pain, positive for HLA-B27 and positive MRI showing acute inflammatory lesions in spine or ISG)
• 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.
• If on prednisone, equal or less than 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 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.

You may not qualify if:

• Definite ankylosing spondylitis (according to modified New York criteria, sacroiliitis ³ grade 2 bilaterally or grade 3 to 4 unilaterally) History of active tuberculosis (TB), histoplasmosis or listeriosis. History of positive HIV status. Positive serology for hepatitis B or C indicating active infection, in case of hepatitis B also if indicating chronic infection 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. Treatment with biologicals within the last 12 weeks If on DMARDs 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.
• History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Participation in trials of other investigational medications within 30 days of entering the study Clinical examination showing significant abnormalities of clinical relevance History or current evidence of abuse of "hard" drugs (e.g. cocaine/heroine) or alcoholism

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Abbott: collaborator

Study Sites (2)

Charité Campus Benjamin Franklin, Rheumatology

Berlin, 12200, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44625, Germany

Location

Related Publications (3)

• Weiss A, Song IH, Haibel H, Listing J, Sieper J. Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers. Arthritis Res Ther. 2014 Jan 30;16(1):R35. doi: 10.1186/ar4464.

  PMID: 24476416 DERIVED

• Haibel H, Heldmann F, Braun J, Listing J, Kupper H, Sieper J. Long-term efficacy of adalimumab after drug withdrawal and retreatment in patients with active non-radiographically evident axial spondyloarthritis who experience a flare. Arthritis Rheum. 2013 Aug;65(8):2211-3. doi: 10.1002/art.38014. No abstract available.

  PMID: 23686466 DERIVED

• Haibel H, Rudwaleit M, Listing J, Heldmann F, Wong RL, Kupper H, Braun J, Sieper J. Efficacy of adalimumab in the treatment of axial spondylarthritis without radiographically defined sacroiliitis: results of a twelve-week randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. Arthritis Rheum. 2008 Jul;58(7):1981-91. doi: 10.1002/art.23606.

  PMID: 18576337 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joachim Sieper, Prof.

  Charité Campus Benjamin Franklin, Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: March 1, 2005
• Study Completion: June 1, 2007
• Last Updated: December 9, 2005

Record last verified: 2005-10

Locations

DE (2)