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Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis

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 May 2008 by Rheumazentrum Ruhrgebiet.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Centocor BV
Trial Coordination Center, 9713 GZ Groningen
PPD
Information provided by:
Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier:
NCT00237419
First received: October 10, 2005
Last updated: May 30, 2008
Last verified: May 2008
  Purpose
Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active AS on a short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on a long-term basis over 4 years is safe and efficient and can prevent radiographic progression over a long period of time. Further we want to learn about the outcome after discontinuation of anti-TNF-alpha therapy.

Condition Intervention
Ankylosing Spondylitis
Drug: infliximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension, Investigator Initiated Trial to Examine Radiographic Progression , Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis. EASIC (European Ankylosing Spondylitis Infliximab Cohort)

Resource links provided by NLM:


Further study details as provided by Rheumazentrum Ruhrgebiet:

Primary Outcome Measures:
  • Degree of structural damage (radiographic progression)after 4 and 6 years of infliximab therapy (2 years of ASSERT trial plus 2 years of EASIC trial) [ Time Frame: November 2008 and November 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients which have received anti-TNF-alpha therapy as standard care after the end of ASSERT [ Time Frame: November 2005 ] [ Designated as safety issue: No ]
  • Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries [ Time Frame: November 2005 ] [ Designated as safety issue: No ]
  • Degree of spinal inflammation analyzed by MRI after discontinuation of infliximab and 4-8 weeks and 2 and 4 years after re-treatment [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • Long-term efficacy of infliximab over 4 and 6 years of therapy measured by the ASAS response criteria [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • Efficacy and safety of a new start of infliximab therapy after discontinuation for several months after 2 and 4 years of continuous treatment [ Time Frame: November 2008 and November 2010 ] [ Designated as safety issue: Yes ]
  • Long-term effects on QoL [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • Long-term effects on health resource utilisation and productivity in paid and unpaid work [ Time Frame: November 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 149
Study Start Date: December 2005
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: infliximab
    Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks
Detailed Description:

Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Chronic inflammation of entheses leads to new bone formation, syndesmophytes and ankylosis of joints, primarily in the axial skeleton. This leads to a dramatic loss of range of motion and to disability. The disease may also have nonskeletal manifestations including uveitis, carditis, pulmonary fibrosis and cardiac conduction abnormalities.

Current therapy for AS is mainly with NSAIDs and physiotherapy which are often insufficient. Clinical outcome with conventional therapies has not been good, with 50-70% of patients progressing to fusion of the spine by 10 to 15 years. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active ankylosing spondylitis on a short- and a long-term basis over 2 years.

There is limited data available on the efficacy and safety of long-term anti-TNF therapy for 3 and more years, the outcome after discontinuation of anti-TNF therapy and the effect of anti-TNF therapy on radiographic progression over a long period of time.

The ASSERT trial was a 2 year international randomized placebo controlled trial to evaluate the efficacy and safety ot treatment with infliximab in patients with active and severe AS. The EASIC trial is initiated to follow the European participants of the ASSERT trial for at least an additional 2 years of treatment combined with systematic data collection.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients in Europe who have completed visit "week 96" of ASSERT (last infusion of infliximab)
  • Capacity to understand and sign an informed consent form
  • Capacity to read and understand subject assessment forms
  • Using adequate birth control measures for the duration of the study and for 6 months after receiving the last infusion, if the patient is of childbearing potential
  • Serum creatinine < 1,4 mg/dl
  • Hemoglobin > 9,0 mg /dl for males and > 8,5 mg/dl for females
  • Serum transaminase levels within 3 times the upper limit of normal range

Exclusion Criteria:

  • Have used systemic prednisolone > 20 mg during the 2 weeks prior to screening
  • Have used cytotoxic drugs after the end of ASSERT including chlorambucil, cyclophosphamide and alkylating agents
  • Have received any previous treatment with etanercept or any other anti-TNF agent (other than infliximab) after the end of the ASSERT trial
  • General medical exclusion criteria
  • Use of any investigational drug within 30 days prio to screening
  • Concomitant diagnosis or history of congestive heart failure
  • History of latent or active tuberculosis
  • Signs or symptoms suggestive of active tuberculosis
  • Recent close contact with a person with active tuberculosis
  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: NCT00237419

Locations
Belgium
Erasme University Hospital
Brussels, Belgium
Limburg University Centre
Diepenbeek, Belgium
Universitair Ziekenhuis, Afdeling Rheumatologie
Gent, Belgium, 9000
University Hospital Leuven
Leuven, Belgium, 3000
Finland
University Central Hospital, Division of Rheumatology
Helsinki, Finland, 00029HYKS
France
Groupe Hopitalier Cochin
Paris, France
Universitat R. Descartes, Hopital Cochin
Paris, France
Germany
Charite Mitte
Berlin, Germany, 10117
Charite Klinikum Steglitz
Berlin, Germany, 12200
Rheumazentrum Ruhrgebiet
Herne, Germany, 44652
Ludwigs-Maximilian-Universität
München, Germany, 80336
Netherlands
Academic Ziekenhuis
Amsterdam, Netherlands, 1007MB
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
United Kingdom
University of Cambridge/ Clin Med
Cambridge, United Kingdom, CB2 QQ
University of Leeds
Leeds, United Kingdom, LS2 9N2
Sponsors and Collaborators
Rheumazentrum Ruhrgebiet
Centocor BV
Trial Coordination Center, 9713 GZ Groningen
PPD
Investigators
Principal Investigator: Jürgen Braun, Prof. Dr. Rheumazentrum Ruhrgebiet
  More Information

Responsible Party: Prof. Dr. Jürgen Braun, Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier: NCT00237419     History of Changes
Other Study ID Numbers: EASIC 30505 
Study First Received: October 10, 2005
Last Updated: May 30, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Rheumazentrum Ruhrgebiet:
Ankylosing spondylitis
Long-term therapy with infliximab
Radiographic progression

Additional relevant MeSH terms:
Disease Progression
Spondylitis
Spondylitis, Ankylosing
Disease Attributes
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 09, 2016