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

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Infliximab

Etanercept

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, TNF-α, Cardiovascular risk, Immunomodulatory activities

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

infliximab

etanercept

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Number of patients who can achieve ACR 20

Correlation of clinical parameter, inflammatory markers and MRI findings

Full Information

NCT ID

NCT00432406

First Posted

February 6, 2007

Last Updated

March 10, 2009

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00432406

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

infliximab

Arm Title

Arm Type

Active Comparator

Arm Description

etanercept

Intervention Type

Drug

Intervention Name(s)

Infliximab

Other Intervention Name(s)

remicade

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etanercept

Other Intervention Name(s)

enbrel

Intervention Description

Etanercept 25 mg twice weekly

Primary Outcome Measure Information:

Title

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

Time Frame

week 52

Title

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

Time Frame

week 52

Secondary Outcome Measure Information:

Title

Number of patients who can achieve ACR 20

Time Frame

week 52

Title

Correlation of clinical parameter, inflammatory markers and MRI findings

Time Frame

week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edmund K Li, MD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

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

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