TNFalfa Blocking Treatment of Spondylarthropathies

NCT00133315 | Completed Phase 4

• 2 other identifiers: 232-001KF 02-050/04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Spondylarthropathies; Ankylosing Spondylitis; Psoriatic Arthritis

Interventions

Infliximab DRUG

Etanercept DRUG

Adalimumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Wish of pregnancy or nursing
• Previous treatment with TNFalfa blocker
• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (9)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Gentofte Hospital

Gentofte Municipality, 2900, Denmark

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Graasten Gighospital

Gråsten, 6300, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Horsens Sygehus

Horsens, 8700, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Related Publications (3)

• 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.

  PMID: 22127697 DERIVED

• 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.

  PMID: 21551511 DERIVED

• 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.

  PMID: 19740906 DERIVED

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

Infliximab; Etanercept; Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized

Study Officials

• Inge Juul Soerensen, MD, Ph.D

  Hvidovre University Hospital, Dept. of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: September 1, 2004
• Study Completion: April 1, 2007
• Last Updated: April 10, 2007

Record last verified: 2007-04

Locations

DK (9)