Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis (Aba-AS-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00558506
First received: November 14, 2007
Last updated: February 25, 2008
Last verified: September 2007
  Purpose

This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to week 30. Abatacept will be administered intravenously according to the prescription used in rheumatoid arthritis.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: abatacept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ASAS40 response rate in TNF-blocker naïve and in TNF-blocker failure patients [ Time Frame: at week 24 ]

Secondary Outcome Measures:
  • Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values [ Time Frame: until week 36 ]
  • ASAS20 response [ Time Frame: througout study ]
  • ASAS partial remission criteria [ Time Frame: throughout study ]
  • BASDAI 20 response [ Time Frame: throughout study ]
  • BASDAI 50 response [ Time Frame: throughout study ]
  • BASFI [ Time Frame: throughout study ]
  • BASMI [ Time Frame: throughout study ]
  • C-reactive protein [ Time Frame: throughout study ]
  • erythrocyte sedimentation rate [ Time Frame: throughout study ]
  • Quality of Life: SF-36, AS-QoL, EQ-5D [ Time Frame: Quality of Life: SF-36, AS-QoL, EQ-5D ]
  • Numeric Rating Scale (NRS) - physicians global, patients global, general pain, nocturnal pain [ Time Frame: throughout the study ]
  • Enthesitis index (Maastricht scale) [ Time Frame: throughout the study ]
  • swollen and tender joint count [ Time Frame: swollen and tender joint count ]
  • Socio-economic questionnaire [ Time Frame: throughout the study ]
  • course of change of active and chronic inflammatory lesions in MRI [ Time Frame: throughout the study ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Abatacept
Drug: abatacept
intravenously 750mg (in patients with weight of 60- 100kg)

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Patients 18 - 65 years of age who have moderate to severe ankylosing spondylitis.

  1. Patients 18- 65 years of age who have moderate to severe ankylosing spondylitis.
  2. Group

    1. TNFalpha inhibitor naïve patients: active AS patients with inadequate response to conventional therapy (e.g. NSAIDs, glucocorticosteroids or DMARDs) or with intolerance of conventional therapy Group
    2. TNFalpha inhibitor failures: active AS patients with inadaequate response to treatment with TNFalpha inhibitors (= patients with previous treatment with TNFalpha inhibitors who showed an inadaquate response according to the international ASAS recommendations; NOT AS patients who had to discontinue TNFalpha inhibitor treatment because of intolerance)
  3. 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 (first group) or prior treatment with TNFalpha inhibitors (second group)
  4. if on NSAIDs, dosage must be stable 2 weeks prior to baseline. During the study dosage should be stable but is allowed to be reduced if documentated.
  5. If on prednisone, <=10.0 mg per day, must be stable for 4 weeks prior to baseline and should be kept stable during the study
  6. If on sulfasalazine or methotrexate, must be stable for 4 weeks prior to baseline
  7. If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFa therapy must have been terminated at least 4 weeks prior to baseline if etanercept was used and at least 8 weeks if infliximab or adalimumab were used.

Exclusion Criteria:

Main Inclusion/Exclusion Criteria

Exclusion criteria related to general health conditions

  1. Current clinical or laboratory evidence of active or latent tuberculosis (TB) and subjects with a history of active TB treated within the last 3 years --> all potential subjects will have a screening chest x-ray at baseline (acceptable if present within the last 3 months); all potential subjects will have a Tuberculin skin test at screening
  2. Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus, Sjögren's syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome (other manifestations of spondyloarthritis such as psoriasis, inflammatory bowel disease, arthritis, uveitis are not regarded as exclusion criteria)
  3. Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
  4. Hepatitis B or C or HIV
  5. Primary or secondary immunodeficiency
  6. History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
  7. A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
  8. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease ( e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month), nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
  9. Neuropathy that can interfere with quality of life and/or pain assessment.
  10. Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
  11. History of current evidence of abuse of "hard" drugs (e.g. cocaine/ heroine) or alcoholism
  12. Known hypersensitivity to any component of the study medication
  13. Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
  14. Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
  15. History of alcohol, drug or chemical abuse within 6 month prior to screening

Exclusion criteria related to medications

  1. if previously on TNFalpha blocking agents, discontinuation of TNFalpha-blocking agents because of intolerance
  2. If on leflunomide, leflunomide must have been terminated at least 8 weeks prior to the first abatacept administration (or ≥ 28 days after 11 days of standard cholestyramine or activated charcoal washout).
  3. If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFa therapy must have been terminated at least 4 weeks prior to the first abatacept adminstration if etanercept was used and at least 8 weeks if infliximab or adalimumab were used
  4. Previous treatment with abatacept
  5. If on sulfasalazine or methotrexate, must be stable for 4 weeks prior to baseline
  6. Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 4 weeks prior to the first abatacept administration
  7. Previous treatment with any investigational agent within 28 days ( or less than 5 terminal half-lives of elimination) of day 1 dose
  8. Previous treatment with i.v. immunoglobulin
  9. Receipt of a live vaccine within 4 weeks prior to treatment
  10. Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit

Exclusion criteria related to lab findings

  1. Haemoglobin < 8.5 g/dl
  2. Neutrophil counts < 2.000 / µl
  3. Platelet count < 125.000 / µl
  4. Lower than 1 x 1000/µl lymphopenia for more than three months prior to inclusion.
  5. Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
  6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal
  7. Positive HIV, hepatitis B or C serology
  8. Any other laboratory test result that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.

Exclusion criteria related to formal aspects

  1. Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the last 30 days.
  2. Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
  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: NCT00558506

Contacts
Contact: Joachim Sieper, MD +49-(0)30-8445- ext 4535 joachim.sieper@charite.de
Contact: In-Ho Song, MD +49-(0)30-8445- ext 4795 in-ho.song@charite.de

Locations
Germany
Charité University Medicine Berlin, Campus Benjamin-Franklin Recruiting
Berlin, Germany, 12200
Contact: Joachim Sieper, MD    +49-(0)30-8445- ext 4547    joachim.sieper@charite.de   
Contact: In-Ho Song, MD    +49-(0)30-8445- ext 4795    in-ho.song@charite.de   
Principal Investigator: Joachim Sieper, MD         
Sub-Investigator: Anna Amtenbrink, MD         
Sub-Investigator: In-Ho Song, MD         
Rheumazentrum Ruhrgebiet Recruiting
Herne, Germany, 44652
Contact: Jürgen Braun, MD    +49-(0)2325-592 ext 138    j.braun@rheumazentrum-ruhrgebiet.de   
Contact: Frank Heldmann, MD    +49-(0)2325-592 ext 709    heldmann@rheumazentrum-ruhrgebiet.de   
Principal Investigator: Jürgen Braun, MD         
Sub-Investigator: Frank Heldmann, MD         
Sub-Investigator: Ertan Saracbasi-Zender, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Bristol-Myers Squibb
Investigators
Principal Investigator: Joachim Sieper, MD Charité University Medicine Berlin, Campus Benjamin Franklin, Medical Department I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00558506     History of Changes
Other Study ID Numbers: ABATACEPT-AS-01
Study First Received: November 14, 2007
Last Updated: February 25, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Ankylosing spondylitis
activity
treatment
clinical trial

Additional relevant MeSH terms:
Bone Diseases, Infectious
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Abatacept
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014