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CompletedNCT00133315Updated Apr 10, 2007

TNFalfa Blocking Treatment of Spondylarthropathies

A Phase 4 interventional study of Infliximab and Etanercept in Spondylarthropathies, Ankylosing Spondylitis and Psoriatic Arthritis, sponsored by Hvidovre University Hospital. Completed at 9 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-10.

Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. In addition, the researchers want to identify predictors for disease progression.

02

Conditions studied

  • Spondylarthropathies
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
03

In context

Spondylarthropathies

65 studies on the registry are indexed under Spondylarthropathies; 10 are open to participants now.

This study's enrollment of 50 is below the median of 67 across 33 interventional studies indexed under Spondylarthropathies.

Browse Spondylarthropathies studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Browse Hvidovre University Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

06

Study locations

9 sites
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • Bispebjerg Hospital
    Copenhagen, 2400, Denmark
  • Gentofte Hospital
    Gentofte Municipality, 2900, Denmark
  • Glostrup Hospital
    Glostrup Municipality, 2600, Denmark
  • Graasten Gighospital
    Gråsten, 6300, Denmark
  • Herlev Hospital
    Herlev, 2730, Denmark
  • Horsens Sygehus
    Horsens, 8700, Denmark
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
  • Vejle Sygehus
    Vejle, 7100, Denmark
07

References and documents

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 22127697 ↗
  • Pedersen 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 21551511 ↗
  • Pedersen 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2004 and a completion of Apr 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2005
First posted
Aug 23, 2005
Start
Sep 2004
CompletionActual
Apr 2007
Last update
Apr 10, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00133315
Lead sponsor
Hvidovre University Hospital
First posted
Aug 23, 2005
Start date
Sep 2004
Completion
Apr 2007
Last update
Apr 10, 2007

Study contacts

Inge Juul Soerensen, MD, Ph.D
principal investigator · Hvidovre University Hospital, Dept. of Rheumatology
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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