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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: Etanercept + Oral Methotrexate (Drug); Etanercept + Placebo for Methotrexate (Drug); Oral Methotrexate + Placebo for Etanercept (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

Summary

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in subjects with psoriatic arthritis. To do this, etanercept alone will be compared to methotrexate alone or to combination etanercept and methotrexate. This study will last approximately 1 year (52 weeks) for an individual subject. Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the subject nor the study doctor can choose the group to which the subject will be randomized into. Subjects will take one study medication by injection under their skin and a second medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the subject and determines that their condition has not improved, the subject may qualify to receive etanercept plus methotrexate.

Clinical Details

Official title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy as measured by American College of Rheumatology (ACR) 20 response.

Secondary outcome:

Minimal Disease Activity (MDA) response of arthritis activity.

Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity.

Minimal Disease Activity (MDA) response of patient reported outcomes.

Detailed description: This is a multicenter, randomized, double-blind controlled study to evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with PsA as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response and Minimal Disease Activity (MDA) at week 24. The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period. Approximately 840 subjects will be randomly assigned in a 1: 1:1 ratio to one of three treatment groups (280 per group): etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly, etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate, and oral methotrexate 20 mg weekly plus placebo for etanercept. Starting at week 24 visit, subjects who have an inadequate response will be provided rescue treatment of etanercept plus methotrexate for the remainder of the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Subject must have a diagnosis of PsA by the Classification Criteria for Psoriatic

Arthritis (CASPAR) criteria.

- Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.

- Subject has an active psoriatic skin lesion

- Subject is naïve to etanercept and any other biologic for the treatment for PsA or

Psoriasis.

- Subject has no prior use of methotrexate for PsA.

- Subject has no history of tuberculosis

- Subject has a negative test for tuberculosis, hepatitis B and C.

Exclusion Criteria:

- Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or

immunodeficiency syndromes, including Human Immunodeficiency Virus infection.

- Subject has any active infection (including chronic or localized infections) for

which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.

- Subject has a serious infection, defined as requiring hospitalization or intravenous

anti-infectives within 8 weeks prior to the first dose of investigational product.

Locations and Contacts

Amgen Call Center, Phone: 866-572-6436

Research Site, Quebec G1V 3M7, Canada; Recruiting

Research Site, Ponce 00716, Puerto Rico; Recruiting

Research Site, San Juan 00918, Puerto Rico; Recruiting

Research Site, Tuscaloosa, Alabama 35406, United States; Recruiting

Research Site, Glendale, Arizona 85304, United States; Recruiting

Research Site, Mesa, Arizona 85202, United States; Recruiting

Research Site, Little Rock, Arkansas 72205, United States; Recruiting

Research Site, Surrey, British Columbia V3R 6A7, Canada; Recruiting

Research Site, Hemet, California 92543, United States; Recruiting

Research Site, Santa Monica, California 90404, United States; Recruiting

Research Site, Thousand Oaks, California 91360, United States; Recruiting

Research Site, Tustin, California 92780, United States; Recruiting

Research Site, Aventura, Florida 33180, United States; Recruiting

Research Site, Dunedin, Florida 34698, United States; Recruiting

Research Site, Tampa, Florida 33609, United States; Recruiting

Research Site, Tampa, Florida 33613, United States; Recruiting

Research Site, Zephyrhills, Florida 33542, United States; Recruiting

Research Site, Springfield, Illinois 62703, United States; Recruiting

Research Site, Bowling Green, Kentucky 42101, United States; Recruiting

Research Site, Paducah, Kentucky 42003, United States; Recruiting

Research Site, Winnipeg, Manitoba R3N 0K6, Canada; Recruiting

Research Site, Frederick, Maryland 21702, United States; Recruiting

Research Site, Worcester, Massachusetts 01605, United States; Recruiting

Research Site, Lansing, Michigan 48910, United States; Recruiting

Research Site, Lansing, Michigan 48917, United States; Recruiting

Research Site, Saint Clair Shores, Michigan 48081, United States; Recruiting

Research Site, Las Vegas, Nevada 89128, United States; Recruiting

Research Site, Lebanon, New Hampshire 03756, United States; Recruiting

Research Site, Clifton, New Jersey 07012, United States; Recruiting

Research Site, Freehold, New Jersey 07728, United States; Recruiting

Research Site, Albuquerque, New Mexico 87102, United States; Recruiting

Research Site, Charlotte, North Carolina 28204, United States; Recruiting

Research Site, Cleveland, Ohio 44109, United States; Recruiting

Research Site, Oklahoma City, Oklahoma 73103, United States; Recruiting

Research Site, London, Ontario N6A 3H7, Canada; Recruiting

Research Site, Toronto, Ontario M5T 2S8, Canada; Recruiting

Research Site, Duncansville, Pennsylvania 16635, United States; Recruiting

Research Site, Wyomissing, Pennsylvania 19610, United States; Recruiting

Research Site, Saskatoon, Saskatchewan S7K 3H3, Canada; Recruiting

Research Site, Rapid City, South Dakota 57701, United States; Recruiting

Research Site, Dallas, Texas 75231, United States; Recruiting

Research Site, Chesapeake, Virginia 23320, United States; Recruiting

Research Site, Roanoke, Virginia 24014, United States; Recruiting

Research Site, Seattle, Washington 98122, United States; Recruiting

Additional Information

AmgenTrials clinical trials website

Starting date: March 2015
Last updated: August 19, 2015

Page last updated: August 23, 2015

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