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

Phase 4
18 Years
70 Years
Not Enrolling
Psoriatic Arthritis

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Trial Information

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

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.

Inclusion Criteria:

- Age 18 or above

- PsA with active disease despite treatment with non-steroidal anti-inflammatory drug

- 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

- 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);

- Any known malignant disease except basal cell carcinoma currently or in the past 5

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels

Outcome Time Frame:

week 52

Safety Issue:


Principal Investigator

Edmund K Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong


Hong Kong: Department of Health

Study ID:




Start Date:

May 2006

Completion Date:

March 2009

Related Keywords:

  • Psoriatic Arthritis
  • Psoriatic Arthritis
  • TNF-α
  • Cardiovascular risk
  • Immunomodulatory activities
  • Arthritis
  • Arthritis, Psoriatic