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

July 8, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

777

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Site Ref # / Investigator 1938
    • South Australia
      • Bedford Park, South Australia, Australia, SA 5042
        • Site Ref # / Investigator 1940
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Site Ref # / Investigator 1935
      • Parkville, Victoria, Australia, 3050
        • Site Ref # / Investigator 1937
  • Belgium
      • Bonheiden, Belgium, 2820
        • Site Ref # / Investigator 1941
      • Brussels, Belgium, 1070
        • Site Ref # / Investigator 5189
      • Leuven, Belgium, 3000
        • Site Ref # / Investigator 2535
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Site Ref # / Investigator 1868
      • Edmonton, Alberta, Canada, T5H 2B9
        • Site Ref # / Investigator 1924
      • Edmonton, Alberta, Canada, T6G2XB
        • Site Ref # / Investigator 426
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Site Ref # / Investigator 1914
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Site Ref # / Investigator 1872
      • Victoria, British Columbia, Canada, V8V 3M9
        • Site Ref # / Investigator 1870
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Site Ref # / Investigator 1874
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Site Ref # / Investigator 1873
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Site Ref # / Investigator 1876
      • London, Ontario, Canada, N6A 5K8
        • Site Ref # / Investigator 1875
      • Toronto, Ontario, Canada, M3N2V7
        • Site Ref # / Investigator 1772
      • Toronto, Ontario, Canada, M5G 1X5
        • Site Ref # / Investigator 1865
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Site Ref # / Investigator 2459
      • Montreal, Quebec, Canada, H3G 1A4
        • Site Ref # / Investigator 1866
      • Quebec City, Quebec, Canada, G1S4L8
        • Site Ref # / Investigator 1863
  • Denmark
      • Arhus C, Denmark, 8000
        • Site Ref # / Investigator 1952
      • Odense C, Denmark, 5000
        • Site Ref # / Investigator 1922
  • France
      • Amiens, France, 80054
        • Site Ref # / Investigator 1964
      • Lillie Cedex, France, 59037
        • Site Ref # / Investigator 2458
      • Paris, France, 74575
        • Site Ref # / Investigator 1913
  • Germany
      • Kiel, Germany, 24105
        • Site Ref # / Investigator 1942
      • Regensburg, Germany, 93053
        • Site Ref # / Investigator 2524
      • Stuttgart, Germany, D-70376
        • Site Ref # / Investigator 1943
  • Hungary
      • Budapest, Hungary, H-1125
        • Site Ref # / Investigator 1944
      • Szekszard, Hungary, 7100
        • Site Ref # / Investigator 1916
  • Italy
      • Bologna, Italy, 40138
        • Site Ref # / Investigator 342
      • Rome, Italy, 00152
        • Site Ref # / Investigator 1945
      • Turin, Italy, 10 158
        • Site Ref # / Investigator 1779
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Site Ref # / Investigator 1919
      • Heerlen, Netherlands, 6419 PC
        • Site Ref # / Investigator 1946
  • Poland
      • Warsaw, Poland, 04-349
        • Site Ref # / Investigator 1947
    • 71-252
      • Szczecin, 71-252, Poland
        • Site Ref # / Investigator 1948
  • South Africa
    • GT
      • Johannesburg, GT, South Africa, 2193
        • Site Ref # / Investigator 1844
    • NL
      • Durban, NL, South Africa, 4091
        • Site Ref # / Investigator 1846
    • WC
      • Cape Town, WC, South Africa, 7708
        • Site Ref # / Investigator 1763
  • Spain
      • Madrid, Spain, 28040
        • Site Ref # / Investigator 341
      • Puerto de Sagunto, Spain, 46520
        • Site Ref # / Investigator 2457
  • Sweden
      • Gothenburg, Sweden, 41345
        • Site Ref # / Investigator 1949
      • Stockholm, Sweden, 114 86
        • Site Ref # / Investigator 1778
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Site Ref # / Investigator 1951
      • Rotherham, United Kingdom, S60 2UD
        • Site Ref # / Investigator 1771
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Site Ref # / Investigator 1894
      • Jacksonville, Alabama, United States, 35801
        • Site Ref # / Investigator 1895
    • California
      • La Jolla, California, United States, 92037
        • Site Ref # / Investigator 1787
      • Roseville, California, United States, 95661
        • Site Ref # / Investigator 1902
      • San Diego, California, United States, 92123
        • Site Ref # / Investigator 1824
      • San Diego, California, United States, 92123
        • Site Ref # / Investigator 1891
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Site Ref # / Investigator 1860
      • Lone Tree, Colorado, United States, 80124
        • Site Ref # / Investigator 6178
      • Wheat Ridge, Colorado, United States, 80033
        • Site Ref # / Investigator 1904
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Site Ref # / Investigator 1858
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site Ref # / Investigator 1827
      • Gainesville, Florida, United States, 32610
        • Site Ref # / Investigator 1883
      • Hollywood, Florida, United States, 33021
        • Site Ref # / Investigator 1909
      • Ormond Beach, Florida, United States, 32174
        • Site Ref # / Investigator 1884
      • Winter Park, Florida, United States, 32789
        • Site Ref # / Investigator 1786
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Site Ref # / Investigator 1912
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Site Ref # / Investigator 1878
      • Chicago, Illinois, United States, 60637
        • Site Ref # / Investigator 2534
      • Peoria, Illinois, United States, 61602
        • Site Ref # / Investigator 1823
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Site Ref # / Investigator 1885
      • Indianapolis, Indiana, United States, 46202
        • Site Ref # / Investigator 1900
      • Indianapolis, Indiana, United States, 46237
        • Site Ref # / Investigator 1890
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Site Ref # / Investigator 1892
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site Ref # / Investigator 1906
    • Maryland
      • Annapolis, Maryland, United States, 24101
        • Site Ref # / Investigator 1881
      • Chevy Chase, Maryland, United States, 20815
        • Site Ref # / Investigator 1829
      • Lutherville, Maryland, United States, 21093
        • Site Ref # / Investigator 1782
      • Silver Spring, Maryland, United States, 20901
        • Site Ref # / Investigator 1887
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Site Ref # / Investigator 2602
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Site Ref # / Investigator 1773
      • Rochester, Minnesota, United States, 55905
        • Site Ref # / Investigator 1856
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site Ref # / Investigator 1832
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Site Ref # / Investigator 1880
      • Mexico, Missouri, United States, 65265
        • Site Ref # / Investigator 1853
      • St. Louis, Missouri, United States, 63110
        • Site Ref # / Investigator 1888
      • St. Louis, Missouri, United States, 63128
        • Site Ref # / Investigator 1862
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Site Ref # / Investigator 1901
    • New York
      • Great Neck, New York, United States, 11021
        • Site Ref # / Investigator 1825
      • Lake Success, New York, United States, 11042
        • Site Ref # / Investigator 1848
      • New York, New York, United States, 10028
        • Site Ref # / Investigator 1841
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Site Ref # / Investigator 1852
      • Charlote, North Carolina, United States, 28211
        • Site Ref # / Investigator 1882
      • Charlotte, North Carolina, United States, 28207
        • Site Ref # / Investigator 1855
      • Raleigh, North Carolina, United States, 27612
        • Site Ref # / Investigator 1911
      • Wilmington, North Carolina, United States, 28403
        • Site Ref # / Investigator 1861
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Site Ref # / Investigator 1784
      • Beaver Creek, Ohio, United States, 45440
        • Site Ref # / Investigator 1896
      • Cincinatti, Ohio, United States, 45219
        • Site Ref # / Investigator 1833
      • Cleveland, Ohio, United States, 44106-5066
        • Site Ref # / Investigator 1826
    • Oregon
      • Portland, Oregon, United States, 97220
        • Site Ref # / Investigator 1822
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15216
        • Site Ref # / Investigator 1886
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Site Ref # / Investigator 1905
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Site Ref # / Investigator 1769
      • Nashville, Tennessee, United States, 37205
        • Site Ref # / Investigator 1907
      • Nashville, Tennessee, United States, 37232
        • Site Ref # / Investigator 1963
    • Texas
      • Round Rock, Texas, United States, 78681
        • Site Ref # / Investigator 1899
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Site Ref # / Investigator 1903
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Site Ref # / Investigator 6180
      • Danville, Virginia, United States, 24541
        • Site Ref # / Investigator 1783
      • Norfolk, Virginia, United States, 23502
        • Site Ref # / Investigator 1897
    • Washington
      • Spokane, Washington, United States, 99204
        • Site Ref # / Investigator 1850
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Site Ref # / Investigator 1831
      • West Bend, Wisconsin, United States, 53095
        • Site Ref # / Investigator 1849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Clinical Remission
Time Frame: Week 156
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Clinical Remission
Time Frame: Week 48
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
Percentage of Subjects Achieving Clinical Remission
Time Frame: Week 108
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
Percentage of Subjects Achieving Clinical Remission
Time Frame: Week 204
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
Percentage of Subjects Achieving Clinical Response 100 (CR-100)
Time Frame: Week 156
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
Percentage of Subjects Achieving Clinical Response 70 (CR-70)
Time Frame: Week 156
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
Percentage of Subjects Achieving Steroid-free Clinical Remission
Time Frame: Week 156
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
Percentage of Subjects Achieving Steroid-free CR-100
Time Frame: Week 156
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
Percentage of Subjects With Fistula Remission
Time Frame: Week 156
Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Week 156
Percentage of Subjects With Infection
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Serious Infection
Time Frame: Up to 262 weeks of adalimumab treatment
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
Percentage of Subjects With Malignancy
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Lymphoma
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Nonmelanoma Skin Cancer
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Injection Site Reaction-related Adverse Event
Time Frame: Up to 262 weeks of adalimumab treatment
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
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Congestive Heart Failure
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Demyelinating Disease
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Hepatic-related Adverse Event
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Allergic Reaction-related Adverse Event
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Lupus-like Syndrome
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Hematologic-related Adverse Event
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Fatal Adverse Event
Time Frame: Up to 262 weeks of adalimumab treatment
Up to 262 weeks of adalimumab treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Anne Camez, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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