TNFalfa Blocking Treatment of Spondylarthropathies

This study has been completed.

Sponsor:

Information provided by:

Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT00133315

First received: August 22, 2005

Last updated: April 9, 2007

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

April 9, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00133315 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

TNFalfa Blocking Treatment of Spondylarthropathies

Official Title ^ICMJE

TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Spondylarthropathies
Ankylosing Spondylitis
Psoriatic Arthritis

Intervention ^ICMJE

Drug: Infliximab
Drug: Etanercept
Drug: Adalimumab

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00133315

Other Study ID Numbers ^ICMJE

232-001, KF 02-050/04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hvidovre University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Inge Juul Soerensen, MD, Ph.D

Hvidovre University Hospital, Dept. of Rheumatology

Information Provided By

Hvidovre University Hospital

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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