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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ankylosing Spondylitis

Keywords

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Ankylosing spondylitis Long-term therapy with infliximab Radiographic progression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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infliximab

Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rheumazentrum Ruhrgebiet

Principal Investigators

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Jürgen Braun, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Rheumazentrum Ruhrgebiet

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Belgium Finland France Germany Netherlands United Kingdom

Central Contacts

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Jürgen Braun, Prof. Dr.

Role: CONTACT

Phone: +49 (0) 2325 592131

Role: backup

References

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Webers C, Essers I, van Tubergen A, Braun J, Heldmann F, Baraliakos X, Boonen A. Valuing Treatment With Infliximab for Ankylosing Spondylitis Using a Willingness-to-Pay Approach. Arthritis Care Res (Hoboken). 2018 Apr;70(4):608-616. doi: 10.1002/acr.23299. Epub 2018 Feb 18.

Reference Type DERIVED

PMID: 28575536 (View on PubMed)

Other Identifiers

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EASIC 30505

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

infliximab

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Centocor BV

Trial Coordination Center, 9713 GZ Groningen

PPD Development, LP

Rheumazentrum Ruhrgebiet

Responsible Party

Principal Investigators

Jürgen Braun, Prof. Dr.

Locations

Erasme University Hospital

Limburg University Centre

Universitair Ziekenhuis, Afdeling Rheumatologie

University Hospital Leuven

University Central Hospital, Division of Rheumatology

Groupe Hopitalier Cochin

Universitat R. Descartes, Hopital Cochin

Charite Mitte

Charite Klinikum Steglitz

Rheumazentrum Ruhrgebiet

Ludwigs-Maximilian-Universität

Academic Ziekenhuis

University Hospital Maastricht

University of Cambridge/ Clin Med

University of Leeds

Countries

Central Contacts

Jürgen Braun, Prof. Dr.

Frank Heldmann, Dr. med.

Facility Contacts

Serge Steinfeld, Prof. Dr.

Piet Geusens, Prof. Dr.

Filip Van den Bosch, Dr.

Kurt de Vlam, Dr.

Rene Westhovens, Prof. Dr.

Marjatta Leirisalo-Repo, Prof

Maxime Breban, Prof.Dr.

Sami Kolta, Dr.

Maxime Dougados, Prof.Dr.

Gerd Burmester, Prof. Dr.

Bettina Marsmann

Henning Brandt, Dr.

Frank Heldmann, Dr.

Jürgen Braun, Prof. Dr.

Christine Strasser

I.E van der Horst-Bruinsma, Dr.

B.A.C Dijkmans, Prof.Dr.

Annelies Boonen

Robert Landewe, Prof. Dr.

Hill Gaston, Prof. Dr.

Mrs. Keen, Dr.

Paul Emery, Prof.Dr.

References

Webers C, Essers I, van Tubergen A, Braun J, Heldmann F, Baraliakos X, Boonen A. Valuing Treatment With Infliximab for Ankylosing Spondylitis Using a Willingness-to-Pay Approach. Arthritis Care Res (Hoboken). 2018 Apr;70(4):608-616. doi: 10.1002/acr.23299. Epub 2018 Feb 18.

Other Identifiers

EASIC 30505