Status:
COMPLETED
Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Psoriatic Arthritis
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week double-blind period, a ≤ 24...
Detailed Description
Previously presented data from 2 double-blind, placebo-controlled trials (Protocols 016.0612 \[Investigator IND\] and 016.0030 \[Immunex IND\]) led to the approval of etanercept for reducing clinical ...
Eligibility Criteria
Inclusion
- Subjects had to satisfy the following criteria before randomization into the study:
- Active PsA at the time of screening, including ≥ 3 swollen joints and ≥ 3 tender/painful joints. • Had ≥ 1 of the following subtypes of PsA: distal interphalangeal (DIP) involvement; polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); arthritis mutilans; asymmetric peripheral arthritis; or ankylosing spondylitis-like.
- Arthritis had demonstrated an inadequate response to nonsteroidal antiinflammatory drug (NSAID) therapy.
- Subjects had plaque psoriasis with qualifying target lesion. Target lesion was to be ≥ 2 cm in diameter and could not be on the scalp, axilla, or groin. Psoriasis was to be stable (ie, not accelerating).
- Between 18 and 70 years of age.
- Subjects remaining on concomitant MTX (≤ 25 mg/week) had inadequate disease control in the opinion of the investigator and had been on a stable dose of MTX for 2 months before start of investigational product. Subjects were required to maintain a stable dose of MTX throughout the study.
- Negative serum pregnancy test within 14 days before the first dose of investigational product in all women (except those surgically sterile or ≥ 5 years postmenopausal).
- Heterosexually active men and women of childbearing potential agreed to use a medically accepted form of contraception throughout the study, including the exclusionary medicine washout period and follow-up period.
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2 times laboratory's upper limit of normal; hemoglobin ≥ 8.5 g/dL; platelet count ≥ 125,000/mm3; white blood cell count ≥ 3,500 cells/mm3; and serum creatinine ≤ 2 mg/dL.
- Negative HIV test. Negative test for hepatitis B surface antigen and hepatitis C.
- Able to reconstitute and self-inject investigational product or have a designee who could do so.
- Capable of understanding and giving written, voluntary informed consent.
Exclusion
- Guttate or pustular psoriasis.
- Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Active severe infection within 1 month of investigational product administration.
- Subjects must be off antibiotics for 1 week before investigational product administration.
- Previous receipt of etanercept, known antibody to TNF, or experimental metalloproteinase inhibitors (past or current use of minocycline and doxycycline was acceptable).
- Receipt of investigational drugs or biologics within 4 weeks of the screening visit.
- Receipt of anti-CD4 or diptheria IL-2 fusion protein within the previous 6 months, with a subsequent abnormal absolute T cell count.
- Psoralen ultraviolet A phototherapy (PUVA) within 4 weeks of investigational product initiation. Ultraviolet B (UVB) phototherapy within 2 weeks of investigational product initiation.
- Receipt of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX (eg, hydroxycholorquine, oral or injectable gold, cyclophosphamide, cyclosporine, azathioprine, D-penicillamine, or sulfasalazine) or intra-articular corticosteroids within 4 weeks before the first dose of investigational product.
- Dose of NSAID greater than the maximum recommended dose in the product information. NSAID dose had to be stable for ≥ 4 weeks before screening evaluation.
- Concomitant corticosteroids \> 10 mg/day of prednisone (or its equivalent). Corticosteroid dose had to be stable for ≥ 4 weeks before screening evaluation.
- Topical steroids, oral retinoids, topical vitamin A or D analog preparations or anthralin within 14 days of baseline. (Exception: Topical therapies were permitted on scalp, axillae, and groin but had to be stable throughout trial.)
- Pregnancy or lactation in women.
- Significant concurrent medical diseases including:
- Diabetes mellitus requiring insulin
- Uncompensated congestive heart failure
- Myocardial infarction within 12 months of screening visit
- Unstable or stable angina pectoris
- Uncontrolled hypertension
- Severe pulmonary disease (requiring medical or oxygen therapy)
- History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) within 5 years of screening visit
- HIV positive, hepatitis B surface antigen, or hepatitis C positive
- Rheumatoid arthritis, systemic lupus, scleroderma, or polymyositis
- Any condition judged by the subject's physician that would cause this study to be detrimental to the subject
- Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00317499
Start Date
April 1 2000
End Date
July 1 2002
Last Update
December 23 2010
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