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Crohn's DiseasePhase 3NCT00195715

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

A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Abbott at 111 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
Adalimumab
Type of treatment
Injection or infusion
How many people
777 participants
Where
111 sitesin 15 countries
Study dates
Sep 2004to Dec 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

111 sites in 15 countries.

111 sites in 15 countries

United States63 sites

  • Site Ref # / Investigator 1885

    Anderson, Indiana, 46016

  • Site Ref # / Investigator 1881

    Annapolis, Maryland, 24101

  • Site Ref # / Investigator 1878

    Arlington Heights, Illinois, 60005

  • Site Ref # / Investigator 1852

    Asheville, North Carolina, 28801

  • Site Ref # / Investigator 1912

    Atlanta, Georgia, 30342

  • Site Ref # / Investigator 1784

    Beachwood, Ohio, 44122

  • Site Ref # / Investigator 1896

    Beavercreek, Ohio, 45440

  • Site Ref # / Investigator 1858

    Bridgeport, Connecticut, 06606

  • Site Ref # / Investigator 1882

    Charlote, North Carolina, 28211

  • Site Ref # / Investigator 1855

    Charlotte, North Carolina, 28207

  • Site Ref # / Investigator 6180

    Charlottesville, Virginia, 22911

  • Site Ref # / Investigator 1829

    Chevy Chase, Maryland, 20815

  • Site Ref # / Investigator 2534

    Chicago, Illinois, 60637

  • Site Ref # / Investigator 1833

    Cincinnati, Ohio, 45219

  • Site Ref # / Investigator 1827

    Clearwater, Florida, 33765

  • Site Ref # / Investigator 1826

    Cleveland, Ohio, 44106-5066

  • Site Ref # / Investigator 1905

    Columbia, South Carolina, 29204

  • Site Ref # / Investigator 1783

    Danville, Virginia, 24541

  • Site Ref # / Investigator 1901

    Egg Harbor, New Jersey, 08234

  • Site Ref # / Investigator 1860

    Englewood, Colorado, 80113

  • Site Ref # / Investigator 1883

    Gainesville, Florida, 32610

  • Site Ref # / Investigator 1769

    Germantown, Tennessee, 38138

  • Site Ref # / Investigator 1825

    Great Neck, New York, 11021

  • Site Ref # / Investigator 1909

    Hollywood, Florida, 33021

  • Site Ref # / Investigator 1894

    Huntsville, Alabama, 35801

  • Site Ref # / Investigator 1900

    Indianapolis, Indiana, 46202

  • Site Ref # / Investigator 1890

    Indianapolis, Indiana, 46237

  • Site Ref # / Investigator 1832

    Jackson, Mississippi, 39202

  • Site Ref # / Investigator 1895

    Jacksonville, Alabama, 35801

  • Site Ref # / Investigator 1880

    Kansas City, Missouri, 64131

  • Site Ref # / Investigator 1787

    La Jolla, California, 92037

  • Site Ref # / Investigator 1848

    Lake Success, New York, 11042

  • Site Ref # / Investigator 1892

    Lexington, Kentucky, 40536

  • Site Ref # / Investigator 6178

    Lone Tree, Colorado, 80124

  • Site Ref # / Investigator 1782

    Lutherville, Maryland, 21093

  • Site Ref # / Investigator 1906

    Metairie, Louisiana, 70006

  • Site Ref # / Investigator 1853

    Mexico, Missouri, 65265

  • Site Ref # / Investigator 1831

    Milwaukee, Wisconsin, 53215

  • Site Ref # / Investigator 1907

    Nashville, Tennessee, 37205

  • Site Ref # / Investigator 1963

    Nashville, Tennessee, 37232

  • Site Ref # / Investigator 1841

    New York, New York, 10028

  • Site Ref # / Investigator 1897

    Norfolk, Virginia, 23502

  • Site Ref # / Investigator 1884

    Ormond Beach, Florida, 32174

  • Site Ref # / Investigator 1823

    Peoria, Illinois, 61602

  • Site Ref # / Investigator 1886

    Pittsburgh, Pennsylvania, 15216

  • Site Ref # / Investigator 1773

    Plymouth, Minnesota, 55446

  • Site Ref # / Investigator 1822

    Portland, Oregon, 97220

  • Site Ref # / Investigator 1911

    Raleigh, North Carolina, 27612

  • Site Ref # / Investigator 1856

    Rochester, Minnesota, 55905

  • Site Ref # / Investigator 1902

    Roseville, California, 95661

  • Site Ref # / Investigator 1899

    Round Rock, Texas, 78681

  • Site Ref # / Investigator 1903

    Salt Lake City, Utah, 84107

  • Site Ref # / Investigator 1824

    San Diego, California, 92123

  • Site Ref # / Investigator 1891

    San Diego, California, 92123

  • Site Ref # / Investigator 1887

    Silver Spring, Maryland, 20901

  • Site Ref # / Investigator 1850

    Spokane, Washington, 99204

  • Site Ref # / Investigator 1888

    St Louis, Missouri, 63110

  • Site Ref # / Investigator 1862

    St Louis, Missouri, 63128

  • Site Ref # / Investigator 1849

    West Bend, Wisconsin, 53095

  • Site Ref # / Investigator 1904

    Wheat Ridge, Colorado, 80033

  • Site Ref # / Investigator 1861

    Wilmington, North Carolina, 28403

  • Site Ref # / Investigator 1786

    Winter Park, Florida, 32789

  • Site Ref # / Investigator 2602

    Worcester, Massachusetts, 01610

Other trials in United States

Canada15 sites

  • Site Ref # / Investigator 1868

    Calgary, Alberta, T2N 4N1

  • Site Ref # / Investigator 1924

    Edmonton, Alberta, T5H 2B9

  • Site Ref # / Investigator 426

    Edmonton, Alberta, T6G2XB

  • Site Ref # / Investigator 1873

    Halifax, Nova Scotia, B3H 2Y9

  • Site Ref # / Investigator 1876

    Hamilton, Ontario, L8N 3Z5

  • Site Ref # / Investigator 1875

    London, Ontario, N6A 5K8

  • Site Ref # / Investigator 2459

    Montreal, Quebec, H3A 1A1

  • Site Ref # / Investigator 1866

    Montreal, Quebec, H3G 1A4

  • Site Ref # / Investigator 1863

    Québec, Quebec, G1S4L8

  • Site Ref # / Investigator 1772

    Toronto, Ontario, M3N2V7

  • Site Ref # / Investigator 1865

    Toronto, Ontario, M5G 1X5

  • Site Ref # / Investigator 1914

    Vancouver, British Columbia, V5Z 1H2

  • Site Ref # / Investigator 1872

    Vancouver, British Columbia, V6Z 1Y6

  • Site Ref # / Investigator 1870

    Victoria, British Columbia, V8V 3M9

  • Site Ref # / Investigator 1874

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Australia4 sites

  • Site Ref # / Investigator 1940

    Bedford Park, South Australia, SA 5042

  • Site Ref # / Investigator 1935

    Box Hill, Victoria, 3128

  • Site Ref # / Investigator 1938

    Camperdown, New South Wales, 2050

  • Site Ref # / Investigator 1937

    Parkville, Victoria, 3050

Other trials in Australia

Belgium3 sites

  • Site Ref # / Investigator 1941

    Bonheiden, 2820

  • Site Ref # / Investigator 5189

    Brussels, 1070

  • Site Ref # / Investigator 2535

    Leuven, 3000

Other trials in Belgium

France3 sites

  • Site Ref # / Investigator 1964

    Amiens, 80054

  • Site Ref # / Investigator 2458

    Lillie Cedex, 59037

  • Site Ref # / Investigator 1913

    Paris, 74575

Other trials in France

Germany3 sites

  • Site Ref # / Investigator 1942

    Kiel, 24105

  • Site Ref # / Investigator 2524

    Regensburg, 93053

  • Site Ref # / Investigator 1943

    Stuttgart, D-70376

Other trials in Germany

Italy3 sites

  • Site Ref # / Investigator 342

    Bologna, 40138

  • Site Ref # / Investigator 1945

    Rome, 00152

  • Site Ref # / Investigator 1779

    Turin, 10 158

Other trials in Italy

South Africa3 sites

  • Site Ref # / Investigator 1763

    Cape Town, WC, 7708

  • Site Ref # / Investigator 1846

    Durban, NL, 4091

  • Site Ref # / Investigator 1844

    Johannesburg, GT, 2193

Other trials in South Africa

Denmark2 sites

  • Site Ref # / Investigator 1952

    Arhus C, 8000

  • Site Ref # / Investigator 1922

    Odense C, 5000

Other trials in Denmark

Hungary2 sites

  • Site Ref # / Investigator 1944

    Budapest, H-1125

  • Site Ref # / Investigator 1916

    Szekszárd, 7100

Other trials in Hungary

Netherlands2 sites

  • Site Ref # / Investigator 1919

    Amsterdam, 1105 AZ

  • Site Ref # / Investigator 1946

    Heerlen, 6419 PC

Other trials in Netherlands

Poland2 sites

  • Site Ref # / Investigator 1948

    Szczecin, 71-252

  • Site Ref # / Investigator 1947

    Warsaw, 04-349

Other trials in Poland

Spain2 sites

  • Site Ref # / Investigator 341

    Madrid, 28040

  • Site Ref # / Investigator 2457

    Port de Sagunt, 46520

Other trials in Spain

Sweden2 sites

  • Site Ref # / Investigator 1949

    Gothenburg, 41345

  • Site Ref # / Investigator 1778

    Stockholm, 114 86

Other trials in Sweden

United Kingdom2 sites

  • Site Ref # / Investigator 1951

    Edinburgh, EH4 2XU

  • Site Ref # / Investigator 1771

    Rotherham, S60 2UD

Other trials in United Kingdom

About this study

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

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
Being tested
Adalimumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 156

Secondary outcomes (24)

  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.

    Measured: Week 48

  2. 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.

    Measured: Week 108

  3. 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.

    Measured: Week 204

  4. 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.

    Measured: Week 156

  5. 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.

    Measured: Week 156

  6. 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.

    Measured: Week 156

  7. 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.

    Measured: Week 156

  8. 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.

    Measured: Week 156

  9. Percentage of Subjects With Infection

    Measured: Up to 262 weeks of adalimumab treatment

  10. 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.

    Measured: Up to 262 weeks of adalimumab treatment

  11. Percentage of Subjects With Malignancy

    Measured: Up to 262 weeks of adalimumab treatment

  12. Percentage of Subjects With Lymphoma

    Measured: Up to 262 weeks of adalimumab treatment

  13. Percentage of Subjects With Nonmelanoma Skin Cancer

    Measured: Up to 262 weeks of adalimumab treatment

  14. Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)

    Measured: Up to 262 weeks of adalimumab treatment

  15. Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)

    Measured: Up to 262 weeks of adalimumab treatment

  16. 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.

    Measured: Up to 262 weeks of adalimumab treatment

  17. Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)

    Measured: Up to 262 weeks of adalimumab treatment

  18. Percentage of Subjects With Congestive Heart Failure

    Measured: Up to 262 weeks of adalimumab treatment

  19. Percentage of Subjects With Demyelinating Disease

    Measured: Up to 262 weeks of adalimumab treatment

  20. Percentage of Subjects With Hepatic-related Adverse Event

    Measured: Up to 262 weeks of adalimumab treatment

  21. Percentage of Subjects With Allergic Reaction-related Adverse Event

    Measured: Up to 262 weeks of adalimumab treatment

  22. Percentage of Subjects With Lupus-like Syndrome

    Measured: Up to 262 weeks of adalimumab treatment

  23. Percentage of Subjects With Hematologic-related Adverse Event

    Measured: Up to 262 weeks of adalimumab treatment

  24. Percentage of Subjects With Fatal Adverse Event

    Measured: Up to 262 weeks of adalimumab treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionMar 2006
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
777 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195715
Sponsor's protocol ID
M04-690
Status last verified
Jul 2011
First submitted
13 Sep 2005
Last updated
12 Jul 2011

Publications

  • 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.

    PubMed 29380251

  • 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.

    PubMed 22704916

  • 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.

    PubMed 19201775

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Abbott at 111 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Canada, Australia, Belgium, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Achieving Clinical Remission (time frame: Week 156). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00195715, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.

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