Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

NCT00735787 | Completed Phase 4 Results

• 1 other identifier: M10-405
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 17

Brief Summary

Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16

  Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

  Week 16

Secondary Outcomes (19)

• Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

• Mean Change From Baseline in ESIF for Palms

  Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28

• Mean Change From Baseline in ESIF for Soles

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

• Number of Subjects With Moderate Improvement in ESIF From Baseline

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

• Number of Subjects With Marked Improvement in ESIF From Baseline

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Study Arms (2)

Placebo/Adalimumab

PLACEBO COMPARATOR

Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.

Biological: Placebo; Biological: Adalimumab

Adalimumab

ACTIVE COMPARATOR

80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.

Biological: Adalimumab

Interventions

Placebo BIOLOGICAL

Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.

Placebo/Adalimumab

Adalimumab BIOLOGICAL

Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.

Also known as: Humira, ABT-D2E7

Adalimumab; Placebo/Adalimumab

Eligibility Criteria

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

You may qualify if:

• Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA \>/=3 and candidates for systemic therapy;
• Patients in good general health
• Able to self-administer injections
• Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis

You may not qualify if:

• Previous treatment with HUMIRA®
• Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
• Other active skin diseases or skin infections
• Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
• Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
• History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
• History of moderate to severe congestive heart failure,
• Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
• History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
• History of clinically significant drug or alcohol abuse in the last 12 months;
• Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
• Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
• Prior exposure to Tysabri® (natalizumab)

Sponsors & Collaborators

• Abbott: lead

Study Sites (17)

Site Reference ID/Investigator# 10168

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 10005

Bakersfield, California, 93309, United States

Location

Site Reference ID/Investigator# 10003

Macon, Georgia, 31217, United States

Location

Site Reference ID/Investigator# 10171

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 10164

East Windsor, New Jersey, 08520, United States

Location

Site Reference ID/Investigator# 10173

Dallas, Texas, 75246-1613, United States

Location

Site Reference ID/Investigator# 11302

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 10166

San Antonio, Texas, 78258, United States

Location

Site Reference ID/Investigator# 10180

Edmonton, Alberta, T5K 1X3, Canada

Location

Site Reference ID/Investigator# 10169

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Site Reference ID/Investigator# 10170

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Site Reference ID/Investigator# 10179

Hamilton, Ontario, L8N 1V6, Canada

Location

Site Reference ID/Investigator# 10004

London, Ontario, N5X 2P1, Canada

Location

Site Reference ID/Investigator# 10177

North Bay, Ontario, P1B 3Z7, Canada

Location

Site Reference ID/Investigator# 10175

Waterloo, Ontario, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 10165

Montreal, Quebec, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 10176

Québec, Quebec, G1V 4X7, Canada

Location

Related Publications (1)

• Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.

  PMID: 21173304 DERIVED

Related Links

• prescribing information

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

Limitations and Caveats

Based on one investigator's non-compliance with the protocol at one site, ITT analyses were conducted in a smaller number of subjects that excluded all 9 subjects from this one site.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott Laboratories

1-800-633-9110

Study Officials

• Martin Okun, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 1, 2010
• Results First Posted: November 1, 2010

Record last verified: 2010-10

Locations

US (8); CA (9)