SpondylarthropathiesPhase 4NCT00133315
TNFalfa Blocking Treatment of Spondylarthropathies
A Phase 4 study testing Infliximab, Etanercept and Adalimumab in people with Spondylarthropathies and Ankylosing Spondylitis, run by Hvidovre University Hospital at 9 sites in Denmark.
Trial summary
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthropathies, Ankylosing Spondylitis, Psoriatic Arthritis
- What is being tested?
- Infliximab, Etanercept and Adalimumab
- How many people
- 50 participants
- Where
- 9 sitesDenmark
- Study dates
- Sep 2004to Apr 2007
- Phase
- Phase 4
- 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
- Age>18 years old
- Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
- Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>3
- No signs of tuberculosis (TB)
- Sufficient contraception
Who cannot join
- Wish of pregnancy or nursing
- Previous treatment with TNFalfa blocker
- Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
- Steroid treatment later than 4 weeks before inclusion
- Immunosuppressing agents later than 4 weeks before inclusion
- Severe infections within 3 months
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- HIV-infection
- Active hepatitis B and C
- Active or latent TB
- Severe chronic diseases
- Heart insufficiency (New York Heart Association [NYHA] 3 and 4)
- Malignancy
- Systemic lupus erythematosus (SLE) or SLE-like disease
- Abuse of narcotics or alcohol
- Major psychiatric disorders
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen, 2400
Gentofte Hospital
Gentofte Municipality, 2900
Glostrup Hospital
Glostrup Municipality, 2600
Graasten Gighospital
Gråsten, 6300
Herlev Hospital
Herlev, 2730
Horsens Sygehus
Horsens, 8700
Hvidovre University Hospital
Hvidovre, 2650
Vejle Sygehus
Vejle, 7100
About this study
Official title: TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.
- Being tested
- Infliximab, Etanercept, Adalimumab
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
EtanerceptDrug
AdalimumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startSep 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondylarthropathiesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Inge Juul Soerensen, MD, Ph.D, Principal investigator, Hvidovre University Hospital, Dept. of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133315
- Sponsor's protocol ID
- 232-001
- Other IDs
- KF 02-050/04
- Status last verified
- Apr 2007
- First submitted
- 22 Aug 2005
- Last updated
- 10 Apr 2007
- Results posted
- No
Publications
Pedersen SJ, Sorensen IJ, Lambert RG, Hermann KG, Garnero P, Johansen JS, Madsen OR, Hansen A, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen KH, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Ostergaard M. Radiographic progression is associated with resolution of systemic inflammation in patients with axial spondylarthritis treated with tumor necrosis factor alpha inhibitors: a study of radiographic progression, inflammation on magnetic resonance imaging, and circulating biomarkers of inflammation, angiogenesis, and cartilage and bone turnover. Arthritis Rheum. 2011 Dec;63(12):3789-800. doi: 10.1002/art.30627.
PubMed 22127697Pedersen SJ, Sorensen IJ, Garnero P, Johansen JS, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Lambert R, Hansen A, Ostergaard M. ASDAS, BASDAI and different treatment responses and their relation to biomarkers of inflammation, cartilage and bone turnover in patients with axial spondyloarthritis treated with TNFalpha inhibitors. Ann Rheum Dis. 2011 Aug;70(8):1375-81. doi: 10.1136/ard.2010.138883. Epub 2011 May 8.
PubMed 21551511Pedersen SJ, Sorensen IJ, Hermann KG, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Johansen JS, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Hansen A, Ostergaard M. Responsiveness of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and clinical and MRI measures of disease activity in a 1-year follow-up study of patients with axial spondyloarthritis treated with tumour necrosis factor alpha inhibitors. Ann Rheum Dis. 2010 Jun;69(6):1065-71. doi: 10.1136/ard.2009.111187. Epub 2009 Sep 9.
PubMed 19740906
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
- ClinicalTrials.gov ID
- NCT00133315
- Acronym / sponsor ID
- 232-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Aug 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.
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.
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 (6 listed)
- Age>18 years old
- Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
- Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>3
- No signs of tuberculosis (TB)
Key exclusion criteria (15 listed)
- Wish of pregnancy or nursing
- Previous treatment with TNFalfa blocker
- Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
- Steroid treatment later than 4 weeks before inclusion
- Immunosuppressing agents later than 4 weeks before inclusion
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 |
|---|---|---|
| Infliximab | Drug | – |
| Etanercept | Drug | – |
| Adalimumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2007.
- Derived from this study: PubMed 22127697Pedersen SJ, Sorensen IJ, Lambert RG, Hermann KG, Garnero P, Johansen JS, Madsen OR, Hansen A, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen KH, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Ostergaard M. Radiographic progression is associated with resolution of systemic inflammation in patients with axial spondylarthritis treated with tumor necrosis factor alpha inhibitors: a study of radiographic progression, inflammation on magnetic resonance imaging, and circulating biomarkers of inflammation, angiogenesis, and cartilage and bone turnover. Arthritis Rheum. 2011 Dec;63(12):3789-800. doi: 10.1002/art.30627.
- Derived from this study: PubMed 21551511Pedersen SJ, Sorensen IJ, Garnero P, Johansen JS, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Lambert R, Hansen A, Ostergaard M. ASDAS, BASDAI and different treatment responses and their relation to biomarkers of inflammation, cartilage and bone turnover in patients with axial spondyloarthritis treated with TNFalpha inhibitors. Ann Rheum Dis. 2011 Aug;70(8):1375-81. doi: 10.1136/ard.2010.138883. Epub 2011 May 8.
- Derived from this study: PubMed 19740906Pedersen SJ, Sorensen IJ, Hermann KG, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Johansen JS, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Hansen A, Ostergaard M. Responsiveness of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and clinical and MRI measures of disease activity in a 1-year follow-up study of patients with axial spondyloarthritis treated with tumour necrosis factor alpha inhibitors. Ann Rheum Dis. 2010 Jun;69(6):1065-71. doi: 10.1136/ard.2009.111187. Epub 2009 Sep 9.
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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.
Inge Juul Soerensen, MD, Ph.D principal investigator
Hvidovre University Hospital, Dept. of Rheumatology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab, Etanercept and Adalimumab in people with Spondylarthropathies and Ankylosing Spondylitis, run by Hvidovre University Hospital at 9 sites in Denmark.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 10 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133315, which also lists 3 linked publications.
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 10 Apr 2007.