Ankylosing SpondylitisNCT00237419
Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis
A study testing infliximab in people with Ankylosing Spondylitis, run by Rheumazentrum Ruhrgebiet at 15 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- infliximab
- Type of treatment
- Injection or infusion
- How many people
- 149 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Dec 2005to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of latent or active tuberculosis
- Signs or symptoms suggestive of active tuberculosis
- Recent close contact with a person with active tuberculosis
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Belgium4 sites, 4 recruiting
- Recruiting
Erasme University Hospital
Brussels
Serge Steinfeld, Prof. Dr., +32 (0) 25 556 745, ssteinfe@ulb.ac.be
Serge Steinfeld, Prof.Dr.
- Recruiting
Limburg University Centre
Diepenbeek
Piet Geusens, Prof. Dr., +32 (0) 89 362977, piet.geusens@ping.be
Piet Geusens, Prof. Dr.
- Recruiting
Universitair Ziekenhuis, Afdeling Rheumatologie
Ghent, 9000
Filip Van den Bosch, Dr., filip.vandenbosch@skynet.be
Filip van den Bosch, Dr.
- Recruiting
University Hospital Leuven
Leuven, 3000
Kurt de Vlam, Dr., +32 (0) 16 332 211, kurt.devlam@pi.be
Rene Westhovens, Prof. Dr., +32 (0) 16 344 792, rene.westhovens@uz.kuleuven.ac.be
Germany4 sites, 4 recruiting
- Recruiting
Charite Mitte
Berlin, 10117
Gerd Burmester, Prof. Dr., +49 (0) 30 45051 3082, gerd.burmester@charite.de
Bettina Marsmann, +49 (0) 30 45051 3025, bettina.marsmann@charite.de
- Recruiting
Charite Klinikum Steglitz
Berlin, 12200
Henning Brandt, Dr., +49 (0) 30 8445 4414, henning.brandt@charite.de
Joachim Sieper, Prof.Dr.
- Recruiting
Rheumazentrum Ruhrgebiet
Herne, 44652
Frank Heldmann, Dr., +49 (0) 2325 592138, heldmann@rheumazentrum-ruhrgebiet.de
Jürgen Braun, Prof. Dr., +49 (0) 2325 592 131, j.braun@rheumazentrum-ruhrgebiet.de
- Recruiting
Ludwigs-Maximilian-Universität
München, 80336
Christine Strasser, +49 (0) 89 51603511, Christine.Strasser@med.uni-muenchen.de
Stefan Schewe, Prof.Dr.
France2 sites, 2 recruiting
- Recruiting
Groupe Hopitalier Cochin
Paris
Maxime Breban, Prof.Dr., +33 (0) 1 49095672, maxime.breban@cch.ap-hop-paris.fr
Maxime Breban, Prof.Dr.
- Recruiting
Universitat R. Descartes, Hopital Cochin
Paris
Sami Kolta, Dr., +33 (0) 1 5841 2584, sami.kolta@cch.ap-hop-paris.fr
Maxime Dougados, Prof.Dr., +33 (0) 1 5841 2562, m-doug@cch.ap-hop-paris.fr
Netherlands2 sites, 2 recruiting
- Recruiting
Academic Ziekenhuis
Amsterdam, 1007MB
I.E van der Horst-Bruinsma, Dr., +31 (0) 20 4443432, IE.vanderHorst@vumc.nl
B.A.C Dijkmans, Prof.Dr., +31 (0) 20 4443432, bac.dijkmans@vumc.nl
- Recruiting
University Hospital Maastricht
Maastricht, 6202 AZ
Annelies Boonen, + 31 (0) 43 388 42 33, aboo@sint.azm.nl
Robert Landewe, Prof. Dr., +31 (0) 43 387 7010, Rlan@sint.azm.nl
United Kingdom2 sites, 2 recruiting
- Recruiting
University of Cambridge/ Clin Med
Cambridge, CB2 QQ
Hill Gaston, Prof. Dr., +44 (0) 1233 330161, jshg2@medschl.cam.ac.uk
Hill Gaston, Prof.Dr.
- Recruiting
University of Leeds
Leeds, LS2 9N2
Mrs. Keen, Dr., +44 (0) 113 392 24848
Paul Emery, Prof.Dr., +44 (0) 113 392 5068, p.emery@leeds.ac.uk
Finland1 site, 1 recruiting
- Recruiting
University Central Hospital, Division of Rheumatology
Helsinki, 00029HYKS
Marjatta Leirisalo-Repo, Prof, Marjatta.Leirisalo-Repo@hus.fi
Marjatta Leirisalo-Repo, Prof. Dr.
About this study
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)
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- infliximab
- Keywords
- Ankylosing spondylitis, Long-term therapy with infliximab, Radiographic progression
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabDrug
Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: November 2005
Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries
Measured: 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
Measured: November 2010
Long-term efficacy of infliximab over 4 and 6 years of therapy measured by the ASAS response criteria
Measured: 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
Measured: November 2008 and November 2010
Long-term effects on QoL
Measured: November 2010
Long-term effects on health resource utilisation and productivity in paid and unpaid work
Measured: November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionNov 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rheumazentrum Ruhrgebiet
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor BV, Trial Coordination Center, 9713 GZ Groningen, PPD Development, LP
- Investigators
- Jürgen Braun, Prof. Dr., Principal investigator, Rheumazentrum Ruhrgebiet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237419
- Sponsor's protocol ID
- EASIC 30505
- Status last verified
- May 2008
- First submitted
- 10 Oct 2005
- Last updated
- 3 Jun 2008
- Results posted
- No
Publications
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.
PubMed 28575536
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00237419
- Acronym / sponsor ID
- EASIC 30505
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, Long-term therapy with infliximab, Radiographic progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Rheumazentrum RuhrgebietUniversity, hospital or other
- Collaborators
- Centocor BV, Trial Coordination Center, 9713 GZ Groningen, PPD Development, LP
- Study start
- Dec 2005
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infliximabInfliximab infusions 5 mg/kg body-weight each 6 to 8 weeks | Drug | – |
Primary outcome
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
7 secondary outcomes
Proportion of patients which have received anti-TNF-alpha therapy as standard care after the end of ASSERT
Time frame: November 2005
Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries
Time frame: 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
Time frame: November 2010
Long-term efficacy of infliximab over 4 and 6 years of therapy measured by the ASAS response criteria
Time frame: 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
Time frame: November 2008 and November 2010
Long-term effects on QoL
Time frame: November 2010
Long-term effects on health resource utilisation and productivity in paid and unpaid work
Time frame: November 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
- Derived from this study: PubMed 28575536Webers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Braun, Prof. Dr. principal investigator
Rheumazentrum Ruhrgebiet
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infliximab in people with Ankylosing Spondylitis, run by Rheumazentrum Ruhrgebiet at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Germany, France, Netherlands, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Braun, Prof. Dr. (+49 (0) 2325 592131, j.braun@rheumazentrum-ruhrgebiet.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2008.