Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis

March 10, 2009 updated by: Chinese University of Hong Kong

TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile

The purpose of this study is:

  • To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with psoriatic arthritis (PsA).
  • To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis (RA).
  • To assess whether the lipid and other cardiovascular risk profiles would improve after anti-TNF-α therapy in patients with PsA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was a 12-week, open-label trial of anti-TNF therapy in 20 consecutive patients (Group 1). Another 20 consecutive patients with active disease whom have met the exclusion criteria, or were unwilling to start anti-TNF therapy for fear of toxicity would be recruited as control patients (Group 2). 20 healthy controls were recruited for comparison of the metabolic risk factors (Group 3). Study visits for groups 1 and 2 were conducted at baseline, weeks 2 and 6, and then week 12.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or above
  • PsA with active disease despite treatment with non-steroidal anti-inflammatory drug (NSAID)
  • 3 or more swollen and tender joints
  • Inadequate response after 4 weeks of, or intolerance to nonsteroidal anti-inflammatory drug therapy.
  • Methotrexate (MTX) is allowed during the study only if it has been taken for at least 3 months previously, with the dosage stable for at least 4 weeks prior to the baseline visit.
  • Prednisone ≤ 10 mg/day and/or nonsteroidal anti-inflammatory drugs must have been taken at stable dosage for at least 2 weeks before entering the trial.
  • Informed consent

Exclusion Criteria:

  • Little or no ability for self-care
  • Used a DMARD other than methotrexate or received intra-articular, intramuscular, or intravenous corticosteroids in the 4 weeks before screening.
  • Topical vitamin A (Neotigason CR) or D analog preparations (Daivonex CR), and anthralin for psoriasis within 2 weeks of baseline.
  • Concurrent treatment with MTX at dosages > 15 mg/week and/or corticosteroids in a prednisone-equivalent dosage of > 10 mg/day.
  • Prior anti-TNF therapy at any time.
  • Infected joint prosthesis during the previous 5 years.
  • Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
  • Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis.
  • Active tuberculosis requiring treatment within the previous 3 years.
  • Opportunistic infections such as herpes zoster within the previous 2 months.
  • Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection.
  • Known hypersensitivity to murine proteins
  • Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
  • A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie, lymph nodes in the posterior triangle of the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly.
  • Any known malignant disease except basal cell carcinoma currently or in the past 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
infliximab
Drug: Infliximab
Infliximab 5 mg/kg given at day 1, week 2, week 6
Other Names:
  • remicade
Active Comparator: 2
etanercept
Drug: Etanercept
Etanercept 25 mg twice weekly
Other Names:
  • enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels
Time Frame: week 52
week 52
Changes in the cardiovascular risk factor levels which are directly mediated by TNF-α
Time Frame: week 52
week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who can achieve ACR 20
Time Frame: week 52
week 52
Correlation of clinical parameter, inflammatory markers and MRI findings
Time Frame: week 52
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Edmund K Li, MD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 7, 2007

Study Record Updates

Last Update Posted (Estimate)

March 11, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSA-2006-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Infliximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe