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 because the information has not been verified recently.
Verified May 2008 by Rheumazentrum Ruhrgebiet.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centocor BV
Trial Coordination Center, 9713 GZ Groningen
PPD Development, CB1 6 GQ Cambridge
Information provided by:
Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier:
NCT00237419
First received: October 10, 2005
Last updated: May 30, 2008
Last verified: May 2008

October 10, 2005
May 30, 2008
December 2005
November 2010   (final data collection date for primary outcome measure)
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 ]
Degree of structural damage (radiographic progression)after 4 years of infliximab therapy (2 years of ASSERT trial plus 2 years of EASIC trial)
Complete list of historical versions of study NCT00237419 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion of patients which have received anti-TNF-alpha therapy as standard care after the end of ASSERT
  • Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries
  • Degree of spinal inflammation analyzed by MRI after discontinuation of infliximab and 4-8 weeks and 2 years after re-treatment
  • Long-term efficacy of infliximab over 4 years of therapy measured by the ASAS response criteria
  • Efficacy and safety of a new start of infliximab therapy after discontinuation for several months after 2 years of continuous treatment
  • Long-term effects on QoL
  • Long-term effects on health resource utilisation and productivity in paid and unpaid work
Not Provided
Not Provided
 
Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis
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)

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: infliximab
Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
149
April 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jürgen Braun, Prof. Dr. +49 (0) 2325 592131 j.braun@rheumazentrum-ruhrgebiet.de
Contact: Frank Heldmann, Dr. med. + 49 (0) 2325 592138 heldmann@rheumazentrum-ruhrgebiet.de
Belgium,   Finland,   France,   Germany,   Netherlands,   United Kingdom
 
NCT00237419
EASIC 30505
Not Provided
Prof. Dr. Jürgen Braun, Rheumazentrum Ruhrgebiet
Rheumazentrum Ruhrgebiet
  • Centocor BV
  • Trial Coordination Center, 9713 GZ Groningen
  • PPD Development, CB1 6 GQ Cambridge
Principal Investigator: Jürgen Braun, Prof. Dr. Rheumazentrum Ruhrgebiet
Rheumazentrum Ruhrgebiet
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP