NCT00237419

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
6 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

4.9 years

First QC Date

October 10, 2005

Last Update Submit

May 30, 2008

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitisLong-term therapy with infliximabRadiographic progression

Outcome Measures

Primary Outcomes (1)

  • 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)

    November 2008 and November 2010

Secondary Outcomes (7)

  • Proportion of patients which have received anti-TNF-alpha therapy as standard care after the end of ASSERT

    November 2005

  • Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries

    November 2005

  • Degree of spinal inflammation analyzed by MRI after discontinuation of infliximab and 4-8 weeks and 2 and 4 years after re-treatment

    November 2010

  • Long-term efficacy of infliximab over 4 and 6 years of therapy measured by the ASAS response criteria

    November 2010

  • Efficacy and safety of a new start of infliximab therapy after discontinuation for several months after 2 and 4 years of continuous treatment

    November 2008 and November 2010

  • +2 more secondary outcomes

Interventions

infliximabDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Erasme University Hospital

Brussels, Belgium

RECRUITING

Limburg University Centre

Diepenbeek, Belgium

RECRUITING

Universitair Ziekenhuis, Afdeling Rheumatologie

Ghent, 9000, Belgium

RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

University Central Hospital, Division of Rheumatology

Helsinki, 00029HYKS, Finland

RECRUITING

Groupe Hopitalier Cochin

Paris, France

RECRUITING

Universitat R. Descartes, Hopital Cochin

Paris, France

RECRUITING

Charite Mitte

Berlin, 10117, Germany

RECRUITING

Charite Klinikum Steglitz

Berlin, 12200, Germany

RECRUITING

Rheumazentrum Ruhrgebiet

Herne, 44652, Germany

RECRUITING

Ludwigs-Maximilian-Universität

München, 80336, Germany

RECRUITING

Academic Ziekenhuis

Amsterdam, 1007MB, Netherlands

RECRUITING

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

RECRUITING

University of Cambridge/ Clin Med

Cambridge, CB2 QQ, United Kingdom

RECRUITING

University of Leeds

Leeds, LS2 9N2, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28575536DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jürgen Braun, Prof. Dr.

    Rheumazentrum Ruhrgebiet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Braun, Prof. Dr.

CONTACT

+49 (0) 2325 592131j.braun@rheumazentrum-ruhrgebiet.de

Frank Heldmann, Dr. med.

CONTACT

+ 49 (0) 2325 592138heldmann@rheumazentrum-ruhrgebiet.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

December 1, 2005

Primary Completion

November 1, 2010

Study Completion

April 1, 2011

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

FI(1)DE(4)FR(2)BE(4)NL(2)GB(2)