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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432406
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : March 11, 2009
Information provided by:
Chinese University of Hong Kong

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Infliximab Drug: Etanercept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile
Study Start Date : May 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Active Comparator: 1
Drug: Infliximab
Infliximab 5 mg/kg given at day 1, week 2, week 6
Other Name: remicade

Active Comparator: 2
Drug: Etanercept
Etanercept 25 mg twice weekly
Other Name: enbrel

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

Secondary Outcome Measures :
  1. Number of patients who can achieve ACR 20 [ Time Frame: week 52 ]
  2. Correlation of clinical parameter, inflammatory markers and MRI findings [ Time Frame: week 52 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432406

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Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
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Responsible Party: Edumun K Li, MD, The Chinese University of Hong Kong Identifier: NCT00432406    
Other Study ID Numbers: PSA-2006-002
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009
Keywords provided by Chinese University of Hong Kong:
Psoriatic Arthritis
Cardiovascular risk
Immunomodulatory activities
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents