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

NCT00195715 | Completed Phase 3 Results

• 1 other identifier: M04-690
• Study Type: interventional
• Target: 777
• Locations: 15 countries
• Sites: 111

Brief 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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (24)

• Percentage of Subjects Achieving Clinical Remission

  Week 48

• Percentage of Subjects Achieving Clinical Remission

  Week 108

• Percentage of Subjects Achieving Clinical Remission

  Week 204

• Percentage of Subjects Achieving Clinical Response 100 (CR-100)

  Week 156

• Percentage of Subjects Achieving Clinical Response 70 (CR-70)

  Week 156

Interventions

Adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, Humira

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (111)

Site Ref # / Investigator 1894

Huntsville, Alabama, 35801, United States

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Site Ref # / Investigator 1895

Jacksonville, Alabama, 35801, United States

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Site Ref # / Investigator 1787

La Jolla, California, 92037, United States

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Site Ref # / Investigator 1902

Roseville, California, 95661, United States

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Site Ref # / Investigator 1824

San Diego, California, 92123, United States

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Site Ref # / Investigator 1891

San Diego, California, 92123, United States

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Site Ref # / Investigator 1860

Englewood, Colorado, 80113, United States

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Site Ref # / Investigator 6178

Lone Tree, Colorado, 80124, United States

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Site Ref # / Investigator 1904

Wheat Ridge, Colorado, 80033, United States

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Site Ref # / Investigator 1858

Bridgeport, Connecticut, 06606, United States

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Site Ref # / Investigator 1827

Clearwater, Florida, 33765, United States

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Site Ref # / Investigator 1883

Gainesville, Florida, 32610, United States

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Site Ref # / Investigator 1909

Hollywood, Florida, 33021, United States

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Site Ref # / Investigator 1884

Ormond Beach, Florida, 32174, United States

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Site Ref # / Investigator 1786

Winter Park, Florida, 32789, United States

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Site Ref # / Investigator 1912

Atlanta, Georgia, 30342, United States

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Site Ref # / Investigator 1878

Arlington Heights, Illinois, 60005, United States

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Site Ref # / Investigator 2534

Chicago, Illinois, 60637, United States

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Site Ref # / Investigator 1823

Peoria, Illinois, 61602, United States

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Site Ref # / Investigator 1885

Anderson, Indiana, 46016, United States

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Site Ref # / Investigator 1900

Indianapolis, Indiana, 46202, United States

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Site Ref # / Investigator 1890

Indianapolis, Indiana, 46237, United States

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Site Ref # / Investigator 1892

Lexington, Kentucky, 40536, United States

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Site Ref # / Investigator 1906

Metairie, Louisiana, 70006, United States

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Site Ref # / Investigator 1881

Annapolis, Maryland, 24101, United States

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Site Ref # / Investigator 1829

Chevy Chase, Maryland, 20815, United States

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Site Ref # / Investigator 1782

Lutherville, Maryland, 21093, United States

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Site Ref # / Investigator 1887

Silver Spring, Maryland, 20901, United States

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Site Ref # / Investigator 2602

Worcester, Massachusetts, 01610, United States

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Site Ref # / Investigator 1773

Plymouth, Minnesota, 55446, United States

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Site Ref # / Investigator 1856

Rochester, Minnesota, 55905, United States

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Site Ref # / Investigator 1832

Jackson, Mississippi, 39202, United States

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Site Ref # / Investigator 1880

Kansas City, Missouri, 64131, United States

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Site Ref # / Investigator 1853

Mexico, Missouri, 65265, United States

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Site Ref # / Investigator 1888

St Louis, Missouri, 63110, United States

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Site Ref # / Investigator 1862

St Louis, Missouri, 63128, United States

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Site Ref # / Investigator 1901

Egg Harbor, New Jersey, 08234, United States

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Site Ref # / Investigator 1825

Great Neck, New York, 11021, United States

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Site Ref # / Investigator 1848

Lake Success, New York, 11042, United States

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Site Ref # / Investigator 1841

New York, New York, 10028, United States

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Site Ref # / Investigator 1852

Asheville, North Carolina, 28801, United States

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Site Ref # / Investigator 1882

Charlote, North Carolina, 28211, United States

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Site Ref # / Investigator 1855

Charlotte, North Carolina, 28207, United States

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Site Ref # / Investigator 1911

Raleigh, North Carolina, 27612, United States

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Site Ref # / Investigator 1861

Wilmington, North Carolina, 28403, United States

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Site Ref # / Investigator 1784

Beachwood, Ohio, 44122, United States

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Site Ref # / Investigator 1896

Beavercreek, Ohio, 45440, United States

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Site Ref # / Investigator 1833

Cincinnati, Ohio, 45219, United States

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Site Ref # / Investigator 1826

Cleveland, Ohio, 44106-5066, United States

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Site Ref # / Investigator 1822

Portland, Oregon, 97220, United States

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Site Ref # / Investigator 1886

Pittsburgh, Pennsylvania, 15216, United States

Location

Site Ref # / Investigator 1905

Columbia, South Carolina, 29204, United States

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Site Ref # / Investigator 1769

Germantown, Tennessee, 38138, United States

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Site Ref # / Investigator 1907

Nashville, Tennessee, 37205, United States

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Site Ref # / Investigator 1963

Nashville, Tennessee, 37232, United States

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Site Ref # / Investigator 1899

Round Rock, Texas, 78681, United States

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Site Ref # / Investigator 1903

Salt Lake City, Utah, 84107, United States

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Site Ref # / Investigator 6180

Charlottesville, Virginia, 22911, United States

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Site Ref # / Investigator 1783

Danville, Virginia, 24541, United States

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Site Ref # / Investigator 1897

Norfolk, Virginia, 23502, United States

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Site Ref # / Investigator 1850

Spokane, Washington, 99204, United States

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Site Ref # / Investigator 1831

Milwaukee, Wisconsin, 53215, United States

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Site Ref # / Investigator 1849

West Bend, Wisconsin, 53095, United States

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Site Ref # / Investigator 1938

Camperdown, New South Wales, 2050, Australia

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Site Ref # / Investigator 1940

Bedford Park, South Australia, SA 5042, Australia

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Site Ref # / Investigator 1935

Box Hill, Victoria, 3128, Australia

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Site Ref # / Investigator 1937

Parkville, Victoria, 3050, Australia

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Site Ref # / Investigator 1941

Bonheiden, 2820, Belgium

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Site Ref # / Investigator 5189

Brussels, 1070, Belgium

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Site Ref # / Investigator 2535

Leuven, 3000, Belgium

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Site Ref # / Investigator 1868

Calgary, Alberta, T2N 4N1, Canada

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Site Ref # / Investigator 1924

Edmonton, Alberta, T5H 2B9, Canada

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Site Ref # / Investigator 426

Edmonton, Alberta, T6G2XB, Canada

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Site Ref # / Investigator 1914

Vancouver, British Columbia, V5Z 1H2, Canada

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Site Ref # / Investigator 1872

Vancouver, British Columbia, V6Z 1Y6, Canada

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Site Ref # / Investigator 1870

Victoria, British Columbia, V8V 3M9, Canada

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Site Ref # / Investigator 1874

Winnipeg, Manitoba, R3A 1R9, Canada

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Site Ref # / Investigator 1873

Halifax, Nova Scotia, B3H 2Y9, Canada

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Site Ref # / Investigator 1876

Hamilton, Ontario, L8N 3Z5, Canada

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Site Ref # / Investigator 1875

London, Ontario, N6A 5K8, Canada

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Site Ref # / Investigator 1772

Toronto, Ontario, M3N2V7, Canada

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Site Ref # / Investigator 1865

Toronto, Ontario, M5G 1X5, Canada

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Site Ref # / Investigator 2459

Montreal, Quebec, H3A 1A1, Canada

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Site Ref # / Investigator 1866

Montreal, Quebec, H3G 1A4, Canada

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Site Ref # / Investigator 1863

Québec, Quebec, G1S4L8, Canada

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Site Ref # / Investigator 1952

Arhus C, 8000, Denmark

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Site Ref # / Investigator 1922

Odense C, 5000, Denmark

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Site Ref # / Investigator 1964

Amiens, 80054, France

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Site Ref # / Investigator 2458

Lillie Cedex, 59037, France

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Site Ref # / Investigator 1913

Paris, 74575, France

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Site Ref # / Investigator 1942

Kiel, 24105, Germany

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Site Ref # / Investigator 2524

Regensburg, 93053, Germany

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Site Ref # / Investigator 1943

Stuttgart, D-70376, Germany

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Site Ref # / Investigator 1944

Budapest, H-1125, Hungary

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Site Ref # / Investigator 1916

Szekszárd, 7100, Hungary

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Site Ref # / Investigator 342

Bologna, 40138, Italy

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Site Ref # / Investigator 1945

Rome, 00152, Italy

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Site Ref # / Investigator 1779

Turin, 10 158, Italy

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Site Ref # / Investigator 1919

Amsterdam, 1105 AZ, Netherlands

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Site Ref # / Investigator 1946

Heerlen, 6419 PC, Netherlands

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Site Ref # / Investigator 1948

Szczecin, 71-252, Poland

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Site Ref # / Investigator 1947

Warsaw, 04-349, Poland

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Site Ref # / Investigator 1844

Johannesburg, GT, 2193, South Africa

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Site Ref # / Investigator 1846

Durban, NL, 4091, South Africa

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Site Ref # / Investigator 1763

Cape Town, WC, 7708, South Africa

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Site Ref # / Investigator 341

Madrid, 28040, Spain

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Site Ref # / Investigator 2457

Port de Sagunt, 46520, Spain

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Site Ref # / Investigator 1949

Gothenburg, 41345, Sweden

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Site Ref # / Investigator 1778

Stockholm, 114 86, Sweden

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Site Ref # / Investigator 1951

Edinburgh, EH4 2XU, United Kingdom

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Site Ref # / Investigator 1771

Rotherham, S60 2UD, United Kingdom

Location

Related Publications (3)

• Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

  PMID: 29380251 DERIVED

• Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

  PMID: 22704916 DERIVED

• Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.

  PMID: 19201775 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal 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

This study was stopped by the sponsor in December 2008 when the pre-specified termination criteria were met. Subjects who continued in the study through the termination date were considered as having completed the study.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Anne Camez, MD

  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: September 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: December 1, 2008
• Last Updated: July 12, 2011
• Results First Posted: January 7, 2010

Record last verified: 2011-07

Locations

BE (3); ZA (3); NL (2); DE (3); FR (3); PL (2); ES (2); AU (4); SE (2); US (63); CA (15); DK (2); GB (2); IT (3); HU (2)