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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00432406
First received: February 6, 2007
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Psoriatic Arthritis
Drug: Infliximab
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • Number of patients who can achieve ACR 20 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
  • Correlation of clinical parameter, inflammatory markers and MRI findings [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
infliximab
Drug: Infliximab
Infliximab 5 mg/kg given at day 1, week 2, week 6
Other Name: remicade
Active Comparator: 2
etanercept
Drug: Etanercept
Etanercept 25 mg twice weekly
Other Name: enbrel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432406

Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Edumun K Li, MD, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00432406     History of Changes
Other Study ID Numbers: PSA-2006-002
Study First Received: February 6, 2007
Last Updated: March 10, 2009
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Psoriatic Arthritis
TNF-α
Cardiovascular risk
Immunomodulatory activities

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Infliximab
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014