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

NCT00195676 | Completed Phase 3 Results

• 2 other identifiers: M03-6582005-000095-41
• Study Type: interventional
• Target: 1,469
• Locations: 10 countries
• Sites: 104

Brief Summary

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the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R

  The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.

  Week 16 of Period R

Other Outcomes (7)

• Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60

  Week 60

• Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120

  Week 120

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60

  Week 60

Study Arms (1)

Adalimumab

OTHER

Drug: adalimumab

Interventions

adalimumab DRUG

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

Also known as: ABT-D2E7, Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (104)

Site Reference ID/Investigator# 1263

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 1259

Buckner 13075 PI, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 2427

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 2433

Tucson, Arizona, 85710, United States

Location

Site Reference ID/Investigator# 100

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 1798

Bakersfield, California, 93309, United States

Location

Site Reference ID/Investigator# 122

Fresno, California, 93720, United States

Location

Site Reference ID/Investigator# 1669

Irvine, California, 92697, United States

Location

Site Reference ID/Investigator# 1285

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 86

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 1679

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 1677

Torrance, California, 90503, United States

Location

Site Reference ID/Investigator# 1269

Longmont, Colorado, 80501, United States

Location

Site Reference ID/Investigator# 1275

New Haven, Connecticut, 06511, United States

Location

Site Reference ID/Investigator# 96

Jacksonville, Florida, 32204, United States

Location

Site Reference ID/Investigator# 2431

Pinellas Park, Florida, 33781, United States

Location

Site Reference ID/Investigator# 1273

South Miami, Florida, 33143, United States

Location

Site Reference ID/Investigator# 2432

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 98

Alpharetta, Georgia, 30022, United States

Location

Site Reference ID/Investigator# 1674

Newnan, Georgia, 30263, United States

Location

Site Reference ID/Investigator# 1670

Snellville, Georgia, 30078, United States

Location

Site Reference ID/Investigator# 1264

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 1801

Maywood, Illinois, 60153, United States

Location

Site Reference ID/Investigator# 1681

Springfield, Illinois, 62702, United States

Location

Site Reference ID/Investigator# 1267

Indianapolis, Indiana, 46256, United States

Location

Site Reference ID/Investigator# 1671

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 1258

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 1281

Shreveport, Louisiana, 71103, United States

Location

Site Reference ID/Investigator# 1668

Andover, Massachusetts, 01810, United States

Location

Site Reference ID/Investigator# 1683

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 83

Worcester, Massachusetts, 01610, United States

Location

Site Reference ID/Investigator# 93

Ann Arbor, Michigan, 48109, United States

Location

Site Reference ID/Investigator# 92

Fridley, Minnesota, 55432, United States

Location

Site Reference ID/Investigator# 1262

Minneapolis, Minnesota, 55455, United States

Location

Site Reference ID/Investigator# 1657

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 89

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 1673

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 2119

New Brunswick, New Jersey, 08903, United States

Location

Site Reference ID/Investigator# 1672

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 1797

New York, New York, 10025, United States

Location

Site Reference ID/Investigator# 95

New York, New York, 10029, United States

Location

Site Reference ID/Investigator# 1655

New York, New York, 10032, United States

Location

Site Reference ID/Investigator# 88

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 1256

Williamsville, New York, 14221, United States

Location

Site Reference ID/Investigator# 1266

Raleigh, North Carolina, 27612, United States

Location

Site Reference ID/Investigator# 1265

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 90

Cleveland, Ohio, 44106, United States

Location

Site Reference ID/Investigator# 2434

Columbus, Ohio, 43212, United States

Location

Site Reference ID/Investigator# 1260

Lake Oswego, Oregon, 97035, United States

Location

Site Reference ID/Investigator# 1667

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 121

Portland, Oregon, 97223, United States

Location

Site Reference ID/Investigator# 1323

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 1277

Philadelphia, Pennsylvania, 19103, United States

Location

Site Reference ID/Investigator# 99

Johnston, Rhode Island, 02919, United States

Location

Site Reference ID/Investigator# 1676

Providence, Rhode Island, 02903, United States

Location

Site Reference ID/Investigator# 97

Greer, South Carolina, 29651, United States

Location

Site Reference ID/Investigator# 5199

Mt. Pleasant, South Carolina, 29464, United States

Location

Site Reference ID/Investigator# 1800

Goodlettsville, Tennessee, 37072, United States

Location

Site Reference ID/Investigator# 1282

Nashville, Tennessee, 37215, United States

Location

Site Reference ID/Investigator# 87

Dallas, Texas, 75246-1613, United States

Location

Site Reference ID/Investigator# 1279

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 1665

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 1268

Tyler, Texas, 75703, United States

Location

Site Reference ID/Investigator# 2079

Salt Lake City, Utah, 84132, United States

Location

Site Reference ID/Investigator# 123

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 1653

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 2181

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 2180

Innsbruck, A-6020, Austria

Location

Site Reference ID/Investigator# 2176

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 2554

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 2179

Edegem, 2650, Belgium

Location

Site Reference ID/Investigator# 1629

Calgary, Alberta, T2S 3B3, Canada

Location

Site Reference ID/Investigator#1641

Edmonton, Alberta, T5K 1X3, Canada

Location

Site Reference ID/Investigator# 104

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Site Reference ID/Investigator# 1635

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Site Reference ID/Investigator# 120

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Site Reference ID/Investigator# 94

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Site Reference ID/Investigator# 1640

Hamilton, Ontario, L8N 1V6, Canada

Location

Site Reference ID/Investigator# 1636

London, Ontario, N5X 2P1, Canada

Location

Site Reference ID/Investigator# 1639

North Bay, Ontario, P1B 3Z7, Canada

Location

Site Reference ID/Investigator# 1633

Toronto, Ontario, M5V 2T3, Canada

Location

Site Reference ID/Investigator# 1631

Waterloo, Ontario, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 103

Windsor, Ontario, N8W 1E6, Canada

Location

Site Reference ID/Investigator# 102

Montreal, Quebec, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 1637

Montreal, Quebec, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 101

Montreal, Quebec, H3H 1V4, Canada

Location

Site Reference ID/Investigator# 1802

Québec, Quebec, G1V 4X7, Canada

Location

Site Reference ID/Investigator# 1647

Westmount, Quebec, H3Z 2S6, Canada

Location

Site Reference ID/Investigator# 2553

Créteil, 94010, France

Location

Site Reference ID/Investigator# 2191

Nice, 06200, France

Location

Site Reference ID/Investigator# 2190

Paris, 75475, France

Location

Site Reference ID/Investigator# 2189

Saint-Etienne, 42055, France

Location

Site Reference ID/Investigator# 2198

Frankfurt, 60590, Germany

Location

Site Reference ID/Investigator# 2543

Kiel, 24105, Germany

Location

Site Reference ID/Investigator# 2188

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 2187

Tübingen, 72076, Germany

Location

Site Reference ID/Investigator# 2178

Gdansk, 80-211, Poland

Location

Site Reference ID/Investigator# 2177

Płock, 09-402, Poland

Location

Site Reference ID/Investigator# 2194

Cagaus, 00725, Puerto Rico

Location

Site Reference ID/Investigator# 5507

Carolina, 00985, Puerto Rico

Location

Site Reference ID/Investigator# 2182

Madrid, 28006, Spain

Location

Site Reference ID/Investigator# 2185

Seville, 41009, Spain

Location

Site Reference ID/Investigator# 2183

Valencia, 46014, Spain

Location

Site Reference ID/Investigator# 2193

Geneva, 1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 21752491 DERIVED

• 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.

  PMID: 21083543 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Martin Okun, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 13, 2011
• Results First Posted: November 19, 2010

Record last verified: 2011-04

Locations

PR (2); ES (3); FR (4); BE (2); AU (3); CH (1); PL (2); DE (4); CA (17); US (66)