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Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

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

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Adalimumab (Biological); Adalimumab (Biological); Placebo (Drug); Adalimumab (Biological); Adalimumab (Biological); Adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Laura Redden, MD, PhD, Study Director, Affiliation: Abbott

Summary

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate

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

Primary outcome:

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24

Change From Baseline in Modified Total Sharp X-ray Score at Week 52

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52

Secondary outcome:

Number of Participants Meeting ACR20 Response Criteria at Week 52

Change From Baseline in Modified Total Sharp X-ray Score at Week 24

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24

Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24

Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24

Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment

Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point

Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point

Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point

Estimated Yearly Progression of Rheumatoid Arthritis

Detailed description: This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat [ITT] population).

Eligibility

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

Criteria:

Inclusion Criteria:

- Age 18 or older and in good health (Investigator discretion) with a recent stable

medical history

- Met American College of Rheumatology (ACR) criteria for diagnosis of active

rheumatoid arthritis (RA) and had at both screening and baseline visits >=6 swollen joints and >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints [DIPs] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs [DMARDs] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)

- Insufficient efficacy with MTX 12. 5 to 25 mg per week (10 mg per week if MTX

intolerant).

- If patient on a second-line treatment (DMARD) other than MTX, he/she had to

discontinue it for at least 28 days before the baseline visit (the washout period).

- Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin

per week.

- Both rheumatoid factor positivity and a C-reactive protein value >=1 mg/dL, or at

least one joint erosion on X-ray. Exclusion Criteria:

- Subject considered by the investigator, for any reason, to be an unsuitable candidate

for the study.

- Female subject who was pregnant or breast-feeding or considering becoming pregnant.

- Preceding treatment with any tumor necrosis factor (TNF) antagonist, including

adalimumab.

- Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.

- Intra-articular, intramuscular, or intravenous administration of corticosteroids

within 4 weeks prior to the screening visit.

- Subject was wheelchair bound or bedridden.

Locations and Contacts

Site Ref # / Investigator 424, Huntsville, Alabama 35801, United States

Site Ref # / Investigator 2510, Mobile, Alabama 36608, United States

Site Ref # / Investigator 475, Calgary, Alberta T2N 4N1, Canada

Site Ref # / Investigator 60729, Phoenix, Arizona 85012, United States

Site Ref # / Investigator 725, Scottsdale, Arizona 85260, United States

Site Ref # / Investigator 495, Penticton, British Columbia V2A 3G8, Canada

Site Ref # / Investigator 2496, Richmond, British Columbia V7C 5L9, Canada

Site Ref # / Investigator 60736, Anaheim, California 92801, United States

Site Ref # / Investigator 360, Escondido, California 92025, United States

Site Ref # / Investigator 469, La Jolla, California 92037, United States

Site Ref # / Investigator 714, La Jolla, California 92037-0943, United States

Site Ref # / Investigator 419, Palm Desert, California 92260, United States

Site Ref # / Investigator 492, San Jose, California 95126, United States

Site Ref # / Investigator 60734, San Louis Obispo, California 93405, United States

Site Ref # / Investigator 60739, Van Nuys, California 91405, United States

Site Ref # / Investigator 712, Danbury, Connecticut 06810, United States

Site Ref # / Investigator 710, Aventura, Florida 33180, United States

Site Ref # / Investigator 498, Dunedin, Florida 34698, United States

Site Ref # / Investigator 499, Orlando, Florida 32806, United States

Site Ref # / Investigator 729, Tampa, Florida 33614, United States

Site Ref # / Investigator 463, Zephyrhills, Florida 33542, United States

Site Ref # / Investigator 2436, Boise, Idaho 83704, United States

Site Ref # / Investigator 485, Idaho Falls, Idaho 83404, United States

Site Ref # / Investigator 60732, Chicago, Illinois 60611, United States

Site Ref # / Investigator 726, Springfield, Illinois 62704, United States

Site Ref # / Investigator 2506, Indianapolis, Indiana 46260, United States

Site Ref # / Investigator 732, South Bend, Indiana 46601, United States

Site Ref # / Investigator 60730, Shawnee Mission, Kansas 66216, United States

Site Ref # / Investigator 467, Wichita, Kansas 67203, United States

Site Ref # / Investigator 494, Wichita, Kansas 67208, United States

Site Ref # / Investigator 491, Lexington, Kentucky 40509, United States

Site Ref # / Investigator 2508, Portland, Maine 04102, United States

Site Ref # / Investigator 2495, Winnipeg, Manitoba R3N OK6, Canada

Site Ref # / Investigator 392, Baltimore, Maryland 21239, United States

Site Ref # / Investigator 354, Cumberland, Maryland 21502, United States

Site Ref # / Investigator 730, Wheaton, Maryland 20902, United States

Site Ref # / Investigator 465, Burlington, Massachusetts 01805, United States

Site Ref # / Investigator 2512, Worcester, Massachusetts 01610, United States

Site Ref # / Investigator 471, Grand Rapids, Michigan 49506, United States

Site Ref # / Investigator 473, Kalamazoo, Michigan 49009, United States

Site Ref # / Investigator 731, Kansas City, Missouri 64114, United States

Site Ref # / Investigator 371, St. Louis, Missouri 63141, United States

Site Ref # / Investigator 482, St. Louis, Missouri 63128, United States

Site Ref # / Investigator 502, St. Louis, Missouri 63110, United States

Site Ref # / Investigator 487, Omaha, Nebraska 68114, United States

Site Ref # / Investigator 353, Concord, New Hampshire 03301, United States

Site Ref # / Investigator 364, Dover, New Hampshire 03820, United States

Site Ref # / Investigator 60726, Mercerville, New Jersey 08619, United States

Site Ref # / Investigator 358, Voorhees, New Jersey 08043, United States

Site Ref # / Investigator 483, Rochester, New York 14609, United States

Site Ref # / Investigator 512, Durham, North Carolina 27704, United States

Site Ref # / Investigator 340, Greensboro, North Carolina 27408, United States

Site Ref # / Investigator 461, Raleigh, North Carolina 27609, United States

Site Ref # / Investigator 500, Raleigh, North Carolina 27609, United States

Site Ref # / Investigator 60731, Raleigh, North Carolina 27612, United States

Site Ref # / Investigator 60737, Salisbury, North Carolina 28144, United States

Site Ref # / Investigator 496, Halifax, Nova Scotia B3H 4K4, Canada

Site Ref # / Investigator 456, Mayfield Village, Ohio 44143, United States

Site Ref # / Investigator 470, Oklahoma City, Oklahoma 73112, United States

Site Ref # / Investigator 60723, Oklahoma, Oklahoma 73112, United States

Site Ref # / Investigator 444, Newmarket, Ontario L3Y 3R7, Canada

Site Ref # / Investigator 2497, Toronto, Ontario M4N 3M5, Canada

Site Ref # / Investigator 421, Toronto, Ontario M5T 2S8, Canada

Site Ref # / Investigator 478, Toronto, Ontario M5L 3L9, Canada

Site Ref # / Investigator 422, Eugene, Oregon 97401, United States

Site Ref # / Investigator 60735, Colmar, Pennsylvania 18915-9671, United States

Site Ref # / Investigator 2507, Duncansville, Pennsylvania 16635, United States

Site Ref # / Investigator 717, East Norriton, Pennsylvania 19401, United States

Site Ref # / Investigator 352, Mechanicsburg, Pennsylvania 17055, United States

Site Ref # / Investigator 480, Wexford, Pennsylvania 15090, United States

Site Ref # / Investigator 2511, Wyomissing, Pennsylvania 19610, United States

Site Ref # / Investigator 60724, Wyomissing, Pennsylvania 19610, United States

Site Ref # / Investigator 363, Montreal, Quebec H3Z 2Z3, Canada

Site Ref # / Investigator 60702, Saskatoon, Saskatchewan S7N 0W8, Canada

Site Ref # / Investigator 718, Charleston, South Carolina 29406, United States

Site Ref # / Investigator 460, Memphis, Tennessee 38119, United States

Site Ref # / Investigator 462, Nashville, Tennessee 37205, United States

Site Ref # / Investigator 716, Austin, Texas 78705, United States

Site Ref # / Investigator 60728, Galveston, Texas 77555-0759, United States

Site Ref # / Investigator 2509, Houston, Texas 77074, United States

Site Ref # / Investigator 510, Houston, Texas 77074, United States

Site Ref # / Investigator 60725, Falls Church, Virginia 22044, United States

Site Ref # / Investigator 711, Richmond, Virginia 23219, United States

Site Ref # / Investigator 509, Seattle, Washington 98166-2967, United States

Site Ref # / Investigator 356, Spokane, Washington 99204, United States

Site Ref # / Investigator 464, Tacoma, Washington 98405, United States

Site Ref # / Investigator 60738, Kenosha, Wisconsin 53142, United States

Additional Information

Starting date: February 2000
Last updated: August 23, 2011

Page last updated: August 23, 2015

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