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

Psoriasis Clinical Trial

Official title:

A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195676
• Other study ID #: M03-658
• Secondary ID: 2005-000095-41
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 11, 2011
• Start date: May 2004
• Est. completion date: October 2009

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

Description:

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 The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 [moderate] or worse).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1469
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• adalimumab
40 mg every other week or 40 mg every week by subcutaneous injection

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 2181	Graz
Austria	Site Reference ID/Investigator# 2180	Innsbruck
Austria	Site Reference ID/Investigator# 2176	Vienna
Belgium	Site Reference ID/Investigator# 2554	Brussels
Belgium	Site Reference ID/Investigator# 2179	Edegem
Canada	Site Reference ID/Investigator# 1629	Calgary	Alberta
Canada	Site Reference ID/Investigator#1641	Edmonton	Alberta
Canada	Site Reference ID/Investigator# 94	Halifax	Nova Scotia
Canada	Site Reference ID/Investigator# 1640	Hamilton	Ontario
Canada	Site Reference ID/Investigator# 1636	London	Ontario
Canada	Site Reference ID/Investigator# 101	Montreal	Quebec
Canada	Site Reference ID/Investigator# 102	Montreal	Quebec
Canada	Site Reference ID/Investigator# 1637	Montreal	Quebec
Canada	Site Reference ID/Investigator# 1639	North Bay	Ontario
Canada	Site Reference ID/Investigator# 1802	Quebec
Canada	Site Reference ID/Investigator# 120	St. John's	Newfoundland and Labrador
Canada	Site Reference ID/Investigator# 1635	St. John's	Newfoundland and Labrador
Canada	Site Reference ID/Investigator# 1633	Toronto	Ontario
Canada	Site Reference ID/Investigator# 104	Vancouver	British Columbia
Canada	Site Reference ID/Investigator# 1631	Waterloo	Ontario
Canada	Site Reference ID/Investigator# 1647	Westmount	Quebec
Canada	Site Reference ID/Investigator# 103	Windsor	Ontario
France	Site Reference ID/Investigator# 2553	Creteil
France	Site Reference ID/Investigator# 2191	Nice
France	Site Reference ID/Investigator# 2190	Paris, Cedex 10
France	Site Reference ID/Investigator# 2189	Saint Etienne
Germany	Site Reference ID/Investigator# 2198	Frankfurt
Germany	Site Reference ID/Investigator# 2543	Kiel
Germany	Site Reference ID/Investigator# 2188	Muenster
Germany	Site Reference ID/Investigator# 2187	Tuebingen
Poland	Site Reference ID/Investigator# 2178	Gdansk
Poland	Site Reference ID/Investigator# 2177	Plock
Puerto Rico	Site Reference ID/Investigator# 2194	Cagaus
Puerto Rico	Site Reference ID/Investigator# 5507	Carolina
Spain	Site Reference ID/Investigator# 2182	Madrid
Spain	Site Reference ID/Investigator# 2185	Seville
Spain	Site Reference ID/Investigator# 2183	Valencia
Switzerland	Site Reference ID/Investigator# 2193	Geneva 14
United States	Site Reference ID/Investigator# 98	Alpharetta	Georgia
United States	Site Reference ID/Investigator# 1668	Andover	Massachusetts
United States	Site Reference ID/Investigator# 93	Ann Arbor	Michigan
United States	Site Reference ID/Investigator# 1798	Bakersfield	California
United States	Site Reference ID/Investigator# 1263	Birmingham	Alabama
United States	Site Reference ID/Investigator# 1683	Boston	Massachusetts
United States	Site Reference ID/Investigator# 1259	Buckner 13075 PI	Alabama
United States	Site Reference ID/Investigator# 1264	Chicago	Illinois
United States	Site Reference ID/Investigator# 1265	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 90	Cleveland	Ohio
United States	Site Reference ID/Investigator# 2434	Columbus	Ohio
United States	Site Reference ID/Investigator# 87	Dallas	Texas
United States	Site Reference ID/Investigator# 122	Fresno	California
United States	Site Reference ID/Investigator# 92	Fridley	Minnesota
United States	Site Reference ID/Investigator# 1800	Goodlettsville	Tennessee
United States	Site Reference ID/Investigator# 97	Greer	South Carolina
United States	Site Reference ID/Investigator# 1323	Hershey	Pennsylvania
United States	Site Reference ID/Investigator# 1279	Houston	Texas
United States	Site Reference ID/Investigator# 1267	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 1671	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 1669	Irvine	California
United States	Site Reference ID/Investigator# 96	Jacksonville	Florida
United States	Site Reference ID/Investigator# 99	Johnston	Rhode Island
United States	Site Reference ID/Investigator# 1260	Lake Oswego	Oregon
United States	Site Reference ID/Investigator# 100	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 1269	Longmont	Colorado
United States	Site Reference ID/Investigator# 1258	Louisville	Kentucky
United States	Site Reference ID/Investigator# 1801	Maywood	Illinois
United States	Site Reference ID/Investigator# 1262	Minneapolis	Minnesota
United States	Site Reference ID/Investigator# 5199	Mount Pleasant	South Carolina
United States	Site Reference ID/Investigator# 1282	Nashville	Tennessee
United States	Site Reference ID/Investigator# 2119	New Brunswick	New Jersey
United States	Site Reference ID/Investigator# 1275	New Haven	Connecticut
United States	Site Reference ID/Investigator# 1655	New York	New York
United States	Site Reference ID/Investigator# 1672	New York	New York
United States	Site Reference ID/Investigator# 1797	New York	New York
United States	Site Reference ID/Investigator# 95	New York	New York
United States	Site Reference ID/Investigator# 1674	Newnan	Georgia
United States	Site Reference ID/Investigator# 123	Norfolk	Virginia
United States	Site Reference ID/Investigator# 1285	Oceanside	California
United States	Site Reference ID/Investigator# 1673	Omaha	Nebraska
United States	Site Reference ID/Investigator# 1277	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 2431	Pinellas Park	Florida
United States	Site Reference ID/Investigator# 121	Portland	Oregon
United States	Site Reference ID/Investigator# 1667	Portland	Oregon
United States	Site Reference ID/Investigator# 1676	Providence	Rhode Island
United States	Site Reference ID/Investigator# 1266	Raleigh	North Carolina
United States	Site Reference ID/Investigator# 88	Rochester	New York
United States	Site Reference ID/Investigator# 2079	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 1665	San Antonio	Texas
United States	Site Reference ID/Investigator# 86	San Diego	California
United States	Site Reference ID/Investigator# 1679	Santa Monica	California
United States	Site Reference ID/Investigator# 2427	Scottsdale	Arizona
United States	Site Reference ID/Investigator# 1653	Seattle	Washington
United States	Site Reference ID/Investigator# 1281	Shreveport	Louisiana
United States	Site Reference ID/Investigator# 1670	Snellville	Georgia
United States	Site Reference ID/Investigator# 1273	South Miami	Florida
United States	Site Reference ID/Investigator# 1681	Springfield	Illinois
United States	Site Reference ID/Investigator# 1657	St. Louis	Missouri
United States	Site Reference ID/Investigator# 89	St. Louis	Missouri
United States	Site Reference ID/Investigator# 1677	Torrance	California
United States	Site Reference ID/Investigator# 2433	Tucson	Arizona
United States	Site Reference ID/Investigator# 1268	Tyler	Texas
United States	Site Reference ID/Investigator# 2432	West Palm Beach	Florida
United States	Site Reference ID/Investigator# 1256	Williamsville	New York
United States	Site Reference ID/Investigator# 83	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No