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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 1894
  • Site Ref # / Investigator 1895
  • Site Ref # / Investigator 1787
  • Site Ref # / Investigator 1902
  • Site Ref # / Investigator 1824
  • Site Ref # / Investigator 1891
  • Site Ref # / Investigator 1860
  • Site Ref # / Investigator 6178
  • Site Ref # / Investigator 1904
  • Site Ref # / Investigator 1858
  • Site Ref # / Investigator 1827
  • Site Ref # / Investigator 1883
  • Site Ref # / Investigator 1909
  • Site Ref # / Investigator 1884
  • Site Ref # / Investigator 1786
  • Site Ref # / Investigator 1912
  • Site Ref # / Investigator 1878
  • Site Ref # / Investigator 2534
  • Site Ref # / Investigator 1823
  • Site Ref # / Investigator 1885
  • Site Ref # / Investigator 1900
  • Site Ref # / Investigator 1890
  • Site Ref # / Investigator 1892
  • Site Ref # / Investigator 1906
  • Site Ref # / Investigator 1881
  • Site Ref # / Investigator 1829
  • Site Ref # / Investigator 1782
  • Site Ref # / Investigator 1887
  • Site Ref # / Investigator 2602
  • Site Ref # / Investigator 1773
  • Site Ref # / Investigator 1856
  • Site Ref # / Investigator 1832
  • Site Ref # / Investigator 1880
  • Site Ref # / Investigator 1853
  • Site Ref # / Investigator 1888
  • Site Ref # / Investigator 1862
  • Site Ref # / Investigator 1901
  • Site Ref # / Investigator 1825
  • Site Ref # / Investigator 1848
  • Site Ref # / Investigator 1841
  • Site Ref # / Investigator 1852
  • Site Ref # / Investigator 1882
  • Site Ref # / Investigator 1855
  • Site Ref # / Investigator 1911
  • Site Ref # / Investigator 1861
  • Site Ref # / Investigator 1784
  • Site Ref # / Investigator 1896
  • Site Ref # / Investigator 1833
  • Site Ref # / Investigator 1826
  • Site Ref # / Investigator 1822
  • Site Ref # / Investigator 1886
  • Site Ref # / Investigator 1905
  • Site Ref # / Investigator 1769
  • Site Ref # / Investigator 1907
  • Site Ref # / Investigator 1963
  • Site Ref # / Investigator 1899
  • Site Ref # / Investigator 1903
  • Site Ref # / Investigator 6180
  • Site Ref # / Investigator 1783
  • Site Ref # / Investigator 1897
  • Site Ref # / Investigator 1850
  • Site Ref # / Investigator 1831
  • Site Ref # / Investigator 1849
  • Site Ref # / Investigator 1938
  • Site Ref # / Investigator 1940
  • Site Ref # / Investigator 1935
  • Site Ref # / Investigator 1937
  • Site Ref # / Investigator 1941
  • Site Ref # / Investigator 5189
  • Site Ref # / Investigator 2535
  • Site Ref # / Investigator 1868
  • Site Ref # / Investigator 1924
  • Site Ref # / Investigator 426
  • Site Ref # / Investigator 1914
  • Site Ref # / Investigator 1872
  • Site Ref # / Investigator 1870
  • Site Ref # / Investigator 1874
  • Site Ref # / Investigator 1873
  • Site Ref # / Investigator 1876
  • Site Ref # / Investigator 1875
  • Site Ref # / Investigator 1772
  • Site Ref # / Investigator 1865
  • Site Ref # / Investigator 2459
  • Site Ref # / Investigator 1866
  • Site Ref # / Investigator 1863
  • Site Ref # / Investigator 1952
  • Site Ref # / Investigator 1922
  • Site Ref # / Investigator 1964
  • Site Ref # / Investigator 2458
  • Site Ref # / Investigator 1913
  • Site Ref # / Investigator 1942
  • Site Ref # / Investigator 2524
  • Site Ref # / Investigator 1943
  • Site Ref # / Investigator 1944
  • Site Ref # / Investigator 1916
  • Site Ref # / Investigator 342
  • Site Ref # / Investigator 1945
  • Site Ref # / Investigator 1779
  • Site Ref # / Investigator 1919
  • Site Ref # / Investigator 1946
  • Site Ref # / Investigator 1948
  • Site Ref # / Investigator 1947
  • Site Ref # / Investigator 1844
  • Site Ref # / Investigator 1846
  • Site Ref # / Investigator 1763
  • Site Ref # / Investigator 341
  • Site Ref # / Investigator 2457
  • Site Ref # / Investigator 1949
  • Site Ref # / Investigator 1778
  • Site Ref # / Investigator 1951
  • Site Ref # / Investigator 1771

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Percentage of Subjects With Infection
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.
Percentage of Subjects With Malignancy
Percentage of Subjects With Lymphoma
Percentage of Subjects With Nonmelanoma Skin Cancer
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
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.
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
Percentage of Subjects With Congestive Heart Failure
Percentage of Subjects With Demyelinating Disease
Percentage of Subjects With Hepatic-related Adverse Event
Percentage of Subjects With Allergic Reaction-related Adverse Event
Percentage of Subjects With Lupus-like Syndrome
Percentage of Subjects With Hematologic-related Adverse Event
Percentage of Subjects With Fatal Adverse Event

Full Information

First Posted
September 13, 2005
Last Updated
July 8, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00195715
Brief Title
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
777 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Adalimumab 40 mg by subcutaneous injection every other week or every week
Primary Outcome Measure Information:
Title
Percentage of Subjects Achieving Clinical Remission
Description
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.
Time Frame
Week 156
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving Clinical Remission
Description
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.
Time Frame
Week 48
Title
Percentage of Subjects Achieving Clinical Remission
Description
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.
Time Frame
Week 108
Title
Percentage of Subjects Achieving Clinical Remission
Description
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.
Time Frame
Week 204
Title
Percentage of Subjects Achieving Clinical Response 100 (CR-100)
Description
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.
Time Frame
Week 156
Title
Percentage of Subjects Achieving Clinical Response 70 (CR-70)
Description
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.
Time Frame
Week 156
Title
Percentage of Subjects Achieving Steroid-free Clinical Remission
Description
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.
Time Frame
Week 156
Title
Percentage of Subjects Achieving Steroid-free CR-100
Description
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.
Time Frame
Week 156
Title
Percentage of Subjects With Fistula Remission
Description
Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Time Frame
Week 156
Title
Percentage of Subjects With Infection
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Serious Infection
Description
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.
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Malignancy
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Lymphoma
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Nonmelanoma Skin Cancer
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Injection Site Reaction-related Adverse Event
Description
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.
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Congestive Heart Failure
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Demyelinating Disease
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Hepatic-related Adverse Event
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Allergic Reaction-related Adverse Event
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Lupus-like Syndrome
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Hematologic-related Adverse Event
Time Frame
Up to 262 weeks of adalimumab treatment
Title
Percentage of Subjects With Fatal Adverse Event
Time Frame
Up to 262 weeks of adalimumab treatment

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
29380251
Citation
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.
Results Reference
derived
PubMed Identifier
22704916
Citation
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.
Results Reference
derived
PubMed Identifier
19201775
Citation
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.
Results Reference
derived

Learn more about this trial

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

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