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Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT00195676

Last Updated: 2011-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1469 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-10-31

Brief Summary

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The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

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Detailed Description

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Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment \[PGA\] of 0, 1, or 2 \[clear, minimal, or mild\]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 \[moderate\] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab

Group Type OTHER

adalimumab

Intervention Type DRUG

40 mg every other week or 40 mg every week by subcutaneous injection

Interventions

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adalimumab

40 mg every other week or 40 mg every week by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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ABT-D2E7 Humira

Eligibility Criteria

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Inclusion Criteria

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subjects who met the requirements from previous adalimumab psoriasis study participation.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Martin Okun, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 1263

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 1259

Buckner 13075 PI, Alabama, United States

Site Status

Site Reference ID/Investigator# 2427

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 2433

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 100

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 1798

Bakersfield, California, United States

Site Status

Site Reference ID/Investigator# 122

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 1669

Irvine, California, United States

Site Status

Site Reference ID/Investigator# 1285

Oceanside, California, United States

Site Status

Site Reference ID/Investigator# 86

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 1679

Santa Monica, California, United States

Site Status

Site Reference ID/Investigator# 1677

Torrance, California, United States

Site Status

Site Reference ID/Investigator# 1269

Longmont, Colorado, United States

Site Status

Site Reference ID/Investigator# 1275

New Haven, Connecticut, United States

Site Status

Site Reference ID/Investigator# 96

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 2431

Pinellas Park, Florida, United States

Site Status

Site Reference ID/Investigator# 1273

South Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 2432

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 98

Alpharetta, Georgia, United States

Site Status

Site Reference ID/Investigator# 1674

Newnan, Georgia, United States

Site Status

Site Reference ID/Investigator# 1670

Snellville, Georgia, United States

Site Status

Site Reference ID/Investigator# 1264

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 1801

Maywood, Illinois, United States

Site Status

Site Reference ID/Investigator# 1681

Springfield, Illinois, United States

Site Status

Site Reference ID/Investigator# 1267

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 1671

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 1258

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 1281

Shreveport, Louisiana, United States

Site Status

Site Reference ID/Investigator# 1668

Andover, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 1683

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 83

Worcester, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 93

Ann Arbor, Michigan, United States

Site Status

Site Reference ID/Investigator# 92

Fridley, Minnesota, United States

Site Status

Site Reference ID/Investigator# 1262

Minneapolis, Minnesota, United States

Site Status

Site Reference ID/Investigator# 1657

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 89

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 1673

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 2119

New Brunswick, New Jersey, United States

Site Status

Site Reference ID/Investigator# 1672

New York, New York, United States

Site Status

Site Reference ID/Investigator# 1797

New York, New York, United States

Site Status

Site Reference ID/Investigator# 95

New York, New York, United States

Site Status

Site Reference ID/Investigator# 1655

New York, New York, United States

Site Status

Site Reference ID/Investigator# 88

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 1256

Williamsville, New York, United States

Site Status

Site Reference ID/Investigator# 1266

Raleigh, North Carolina, United States

Site Status

Site Reference ID/Investigator# 1265

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 90

Cleveland, Ohio, United States

Site Status

Site Reference ID/Investigator# 2434

Columbus, Ohio, United States

Site Status

Site Reference ID/Investigator# 1260

Lake Oswego, Oregon, United States

Site Status

Site Reference ID/Investigator# 1667

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 121

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 1323

Hershey, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 1277

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 99

Johnston, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 1676

Providence, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 97

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 5199

Mt. Pleasant, South Carolina, United States

Site Status

Site Reference ID/Investigator# 1800

Goodlettsville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 1282

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 87

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 1279

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 1665

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 1268

Tyler, Texas, United States

Site Status

Site Reference ID/Investigator# 2079

Salt Lake City, Utah, United States

Site Status

Site Reference ID/Investigator# 123

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 1653

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 2181

Graz, , Austria

Site Status

Site Reference ID/Investigator# 2180

Innsbruck, , Austria

Site Status

Site Reference ID/Investigator# 2176

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 2554

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 2179

Edegem, , Belgium

Site Status

Site Reference ID/Investigator# 1629

Calgary, Alberta, Canada

Site Status

Site Reference ID/Investigator#1641

Edmonton, Alberta, Canada

Site Status

Site Reference ID/Investigator# 104

Vancouver, British Columbia, Canada

Site Status

Site Reference ID/Investigator# 1635

St. John's, Newfoundland and Labrador, Canada

Site Status

Site Reference ID/Investigator# 120

St. John's, Newfoundland and Labrador, Canada

Site Status

Site Reference ID/Investigator# 94

Halifax, Nova Scotia, Canada

Site Status

Site Reference ID/Investigator# 1640

Hamilton, Ontario, Canada

Site Status

Site Reference ID/Investigator# 1636

London, Ontario, Canada

Site Status

Site Reference ID/Investigator# 1639

North Bay, Ontario, Canada

Site Status

Site Reference ID/Investigator# 1633

Toronto, Ontario, Canada

Site Status

Site Reference ID/Investigator# 1631

Waterloo, Ontario, Canada

Site Status

Site Reference ID/Investigator# 103

Windsor, Ontario, Canada

Site Status

Site Reference ID/Investigator# 102

Montreal, Quebec, Canada

Site Status

Site Reference ID/Investigator# 1637

Montreal, Quebec, Canada

Site Status

Site Reference ID/Investigator# 101

Montreal, Quebec, Canada

Site Status

Site Reference ID/Investigator# 1802

Québec, Quebec, Canada

Site Status

Site Reference ID/Investigator# 1647

Westmount, Quebec, Canada

Site Status

Site Reference ID/Investigator# 2553

Créteil, , France

Site Status

Site Reference ID/Investigator# 2191

Nice, , France

Site Status

Site Reference ID/Investigator# 2190

Paris, , France

Site Status

Site Reference ID/Investigator# 2189

Saint-Etienne, , France

Site Status

Site Reference ID/Investigator# 2198

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 2543

Kiel, , Germany

Site Status

Site Reference ID/Investigator# 2188

Münster, , Germany

Site Status

Site Reference ID/Investigator# 2187

Tübingen, , Germany

Site Status

Site Reference ID/Investigator# 2178

Gdansk, , Poland

Site Status

Site Reference ID/Investigator# 2177

Płock, , Poland

Site Status

Site Reference ID/Investigator# 2194

Cagaus, , Puerto Rico

Site Status

Site Reference ID/Investigator# 5507

Carolina, , Puerto Rico

Site Status

Site Reference ID/Investigator# 2182

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 2185

Seville, , Spain

Site Status

Site Reference ID/Investigator# 2183

Valencia, , Spain

Site Status

Site Reference ID/Investigator# 2193

Geneva, , Switzerland

Site Status

Countries

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United States Austria Belgium Canada France Germany Poland Puerto Rico Spain Switzerland

References

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Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.

Reference Type DERIVED
PMID: 21752491 (View on PubMed)

Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.

Reference Type DERIVED
PMID: 21083543 (View on PubMed)

Other Identifiers

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2005-000095-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M03-658

Identifier Type: -

Identifier Source: org_study_id

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