Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195715
• Other study ID #: M04-690
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 8, 2011
• Start date: September 2004
• Est. completion date: December 2008

Study information

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

Clinical Trial Summary

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 777
• Est. completion date: December 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study

• Diagnosis of Crohn's disease

• Willing and able to give informed consent

Exclusion Criteria:

• Diagnosis of ulcerative colitis

• Women cannot be pregnant or breastfeeding

• Previous history of listeria infection or untreated tuberculosis

• Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Adalimumab
Adalimumab 40 mg by subcutaneous injection every other week or every week

Locations

Country	Name	City	State
Australia	Site Ref # / Investigator 1940	Bedford Park	South Australia
Australia	Site Ref # / Investigator 1935	Box Hill	Victoria
Australia	Site Ref # / Investigator 1938	Camperdown	New South Wales
Australia	Site Ref # / Investigator 1937	Parkville	Victoria
Belgium	Site Ref # / Investigator 1941	Bonheiden
Belgium	Site Ref # / Investigator 5189	Brussels
Belgium	Site Ref # / Investigator 2535	Leuven
Canada	Site Ref # / Investigator 1868	Calgary	Alberta
Canada	Site Ref # / Investigator 1924	Edmonton	Alberta
Canada	Site Ref # / Investigator 426	Edmonton	Alberta
Canada	Site Ref # / Investigator 1873	Halifax	Nova Scotia
Canada	Site Ref # / Investigator 1876	Hamilton	Ontario
Canada	Site Ref # / Investigator 1875	London	Ontario
Canada	Site Ref # / Investigator 1866	Montreal	Quebec
Canada	Site Ref # / Investigator 2459	Montreal	Quebec
Canada	Site Ref # / Investigator 1863	Quebec City	Quebec
Canada	Site Ref # / Investigator 1772	Toronto	Ontario
Canada	Site Ref # / Investigator 1865	Toronto	Ontario
Canada	Site Ref # / Investigator 1872	Vancouver	British Columbia
Canada	Site Ref # / Investigator 1914	Vancouver	British Columbia
Canada	Site Ref # / Investigator 1870	Victoria	British Columbia
Canada	Site Ref # / Investigator 1874	Winnipeg	Manitoba
Denmark	Site Ref # / Investigator 1952	Arhus C
Denmark	Site Ref # / Investigator 1922	Odense C
France	Site Ref # / Investigator 1964	Amiens
France	Site Ref # / Investigator 2458	Lillie Cedex
France	Site Ref # / Investigator 1913	Paris
Germany	Site Ref # / Investigator 1942	Kiel
Germany	Site Ref # / Investigator 2524	Regensburg
Germany	Site Ref # / Investigator 1943	Stuttgart
Hungary	Site Ref # / Investigator 1944	Budapest
Hungary	Site Ref # / Investigator 1916	Szekszard
Italy	Site Ref # / Investigator 342	Bologna
Italy	Site Ref # / Investigator 1945	Rome
Italy	Site Ref # / Investigator 1779	Turin
Netherlands	Site Ref # / Investigator 1919	Amsterdam
Netherlands	Site Ref # / Investigator 1946	Heerlen
Poland	Site Ref # / Investigator 1948	Szczecin	71-252
Poland	Site Ref # / Investigator 1947	Warsaw
South Africa	Site Ref # / Investigator 1763	Cape Town	WC
South Africa	Site Ref # / Investigator 1846	Durban	NL
South Africa	Site Ref # / Investigator 1844	Johannesburg	GT
Spain	Site Ref # / Investigator 341	Madrid
Spain	Site Ref # / Investigator 2457	Puerto de Sagunto
Sweden	Site Ref # / Investigator 1949	Gothenburg
Sweden	Site Ref # / Investigator 1778	Stockholm
United Kingdom	Site Ref # / Investigator 1951	Edinburgh
United Kingdom	Site Ref # / Investigator 1771	Rotherham
United States	Site Ref # / Investigator 1885	Anderson	Indiana
United States	Site Ref # / Investigator 1881	Annapolis	Maryland
United States	Site Ref # / Investigator 1878	Arlington Heights	Illinois
United States	Site Ref # / Investigator 1852	Asheville	North Carolina
United States	Site Ref # / Investigator 1912	Atlanta	Georgia
United States	Site Ref # / Investigator 1784	Beachwood	Ohio
United States	Site Ref # / Investigator 1896	Beaver Creek	Ohio
United States	Site Ref # / Investigator 1858	Bridgeport	Connecticut
United States	Site Ref # / Investigator 1882	Charlote	North Carolina
United States	Site Ref # / Investigator 1855	Charlotte	North Carolina
United States	Site Ref # / Investigator 6180	Charlottesville	Virginia
United States	Site Ref # / Investigator 1829	Chevy Chase	Maryland
United States	Site Ref # / Investigator 2534	Chicago	Illinois
United States	Site Ref # / Investigator 1833	Cincinatti	Ohio
United States	Site Ref # / Investigator 1827	Clearwater	Florida
United States	Site Ref # / Investigator 1826	Cleveland	Ohio
United States	Site Ref # / Investigator 1905	Columbia	South Carolina
United States	Site Ref # / Investigator 1783	Danville	Virginia
United States	Site Ref # / Investigator 1901	Egg Harbor Township	New Jersey
United States	Site Ref # / Investigator 1860	Englewood	Colorado
United States	Site Ref # / Investigator 1883	Gainesville	Florida
United States	Site Ref # / Investigator 1769	Germantown	Tennessee
United States	Site Ref # / Investigator 1825	Great Neck	New York
United States	Site Ref # / Investigator 1909	Hollywood	Florida
United States	Site Ref # / Investigator 1894	Huntsville	Alabama
United States	Site Ref # / Investigator 1890	Indianapolis	Indiana
United States	Site Ref # / Investigator 1900	Indianapolis	Indiana
United States	Site Ref # / Investigator 1832	Jackson	Mississippi
United States	Site Ref # / Investigator 1895	Jacksonville	Alabama
United States	Site Ref # / Investigator 1880	Kansas City	Missouri
United States	Site Ref # / Investigator 1787	La Jolla	California
United States	Site Ref # / Investigator 1848	Lake Success	New York
United States	Site Ref # / Investigator 1892	Lexington	Kentucky
United States	Site Ref # / Investigator 6178	Lone Tree	Colorado
United States	Site Ref # / Investigator 1782	Lutherville	Maryland
United States	Site Ref # / Investigator 1906	Metairie	Louisiana
United States	Site Ref # / Investigator 1853	Mexico	Missouri
United States	Site Ref # / Investigator 1831	Milwaukee	Wisconsin
United States	Site Ref # / Investigator 1907	Nashville	Tennessee
United States	Site Ref # / Investigator 1963	Nashville	Tennessee
United States	Site Ref # / Investigator 1841	New York	New York
United States	Site Ref # / Investigator 1897	Norfolk	Virginia
United States	Site Ref # / Investigator 1884	Ormond Beach	Florida
United States	Site Ref # / Investigator 1823	Peoria	Illinois
United States	Site Ref # / Investigator 1886	Pittsburgh	Pennsylvania
United States	Site Ref # / Investigator 1773	Plymouth	Minnesota
United States	Site Ref # / Investigator 1822	Portland	Oregon
United States	Site Ref # / Investigator 1911	Raleigh	North Carolina
United States	Site Ref # / Investigator 1856	Rochester	Minnesota
United States	Site Ref # / Investigator 1902	Roseville	California
United States	Site Ref # / Investigator 1899	Round Rock	Texas
United States	Site Ref # / Investigator 1903	Salt Lake City	Utah
United States	Site Ref # / Investigator 1824	San Diego	California
United States	Site Ref # / Investigator 1891	San Diego	California
United States	Site Ref # / Investigator 1887	Silver Spring	Maryland
United States	Site Ref # / Investigator 1850	Spokane	Washington
United States	Site Ref # / Investigator 1862	St. Louis	Missouri
United States	Site Ref # / Investigator 1888	St. Louis	Missouri
United States	Site Ref # / Investigator 1849	West Bend	Wisconsin
United States	Site Ref # / Investigator 1904	Wheat Ridge	Colorado
United States	Site Ref # / Investigator 1861	Wilmington	North Carolina
United States	Site Ref # / Investigator 1786	Winter Park	Florida
United States	Site Ref # / Investigator 2602	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156	No
Secondary	Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 48	No
Secondary	Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 108	No
Secondary	Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 204	No
Secondary	Percentage of Subjects Achieving Clinical Response 100 (CR-100)	A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156	No
Secondary	Percentage of Subjects Achieving Clinical Response 70 (CR-70)	A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156	No
Secondary	Percentage of Subjects Achieving Steroid-free Clinical Remission	Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156	No
Secondary	Percentage of Subjects Achieving Steroid-free CR-100	Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156	No
Secondary	Percentage of Subjects With Fistula Remission	Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.	Week 156	No
Secondary	Percentage of Subjects With Infection		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Serious Infection	Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.	Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Malignancy		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Lymphoma		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Nonmelanoma Skin Cancer		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Injection Site Reaction-related Adverse Event	An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.	Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Congestive Heart Failure		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Demyelinating Disease		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Hepatic-related Adverse Event		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Allergic Reaction-related Adverse Event		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Lupus-like Syndrome		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Hematologic-related Adverse Event		Up to 262 weeks of adalimumab treatment	Yes
Secondary	Percentage of Subjects With Fatal Adverse Event		Up to 262 weeks of adalimumab treatment	Yes