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

NCT00432406 | Completed Phase 4

• 1 other identifier: PSA-2006-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; TNF-α; Cardiovascular risk; Immunomodulatory activities

Outcome Measures

Primary Outcomes (2)

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

  week 52

• Changes in the cardiovascular risk factor levels which are directly mediated by TNF-α

  week 52

Secondary Outcomes (2)

• Number of patients who can achieve ACR 20

  week 52

• Correlation of clinical parameter, inflammatory markers and MRI findings

  week 52

Study Arms (2)

1

ACTIVE COMPARATOR

infliximab

Drug: Infliximab

2

ACTIVE COMPARATOR

etanercept

Drug: Etanercept

Interventions

Infliximab DRUG

Infliximab 5 mg/kg given at day 1, week 2, week 6

Also known as: remicade

1

Etanercept DRUG

Etanercept 25 mg twice weekly

Also known as: enbrel

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• PsA with active disease despite treatment with non-steroidal anti-inflammatory drug (NSAID)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Infliximab; Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Edmund K Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: May 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 11, 2009

Record last verified: 2009-03

Locations

CN (1)