Open-Label Adalimumab for Ulcerative Colitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421642
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : August 1, 2012
Information provided by:
Mayo Clinic

Brief Summary:
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Adalimumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients
Study Start Date : October 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Intervention Details:
    Drug: Adalimumab
    The loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly.
    Other Name: Humira

Primary Outcome Measures :
  1. The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8 [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Clinical remission at each visit [ Time Frame: 24 Weeks ]
  2. Clinical response at each visit [ Time Frame: 24 Weeks ]
  3. Improvement in the mucosal inflammation at week 8 [ Time Frame: 24 Weeks ]
  4. Mayo Score [ Time Frame: 24 Weeks ]
  5. Ability to taper and discontinue steroids according to the tapering schedule after week 8 [ Time Frame: 24 Weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Males and females 18 years of age and older
  2. Female subjects must utilize a highly effective method of birth control throughout the study and for 70 days after study completion, or female subjects must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  3. A diagnosis of UC for greater than 3 months.
  4. UC diagnosis confirmed by endoscopy with exclusion of infectious cause.
  5. Active ulcerative colitis with a Mayo Clinic Score (see Appendix C) of 6 to 12 points with moderately-to-severely active disease on sigmoidoscopy (endoscopic subscore of at least 2) despite concurrent treatment with corticosteroids, and/or azathioprine or 6 mercaptopurine and/or 5-aminosalicylate-containing medications. Patients who previously have not responded to or could not tolerate corticosteroids (within the past 18 months), or azathioprine or 6 mercaptopurine (both within the past 5 years), or 5 aminosalicylate-containing medications (within the past 18 months) will not required to be taking concurrent therapy at enrollment.
  6. Either anti-TNF agent naïve or those with previous clinical response to infliximab therapy for UC with subsequent loss of response AND/OR are unable to tolerate further infliximab therapy for UC due to acute or delayed reactions, as defined by the investigator.
  7. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
  8. Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.

Exclusion Criteria

  1. History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin.
  2. Subjects with a history of Listeria, Hepatitis B infection, central nervous system (CNS) demyelinating disease, or human immunodeficiency virus (HIV) or a history of previously untreated TB. See Appendix B.
  3. Subjects with Crohn?s Disease
  4. Subjects with symptomatic obstructive strictures
  5. Subjects who have had subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for ulcerative colitis or are planning subtotal colectomy or colectomy within 8 weeks of starting the study medication.
  6. Subjects who are currently receiving total parenteral nutrition (TPN).
  7. Any investigational chemical agent in the past 30 days or 5 half-lives prior to screening (whichever is longer). Patients who have previously been treated with infliximab and responded, and then become intolerant to infliximab or lost response, can be treated >/= 4 weeks from their last infliximab dose.
  8. Antibiotic treatment for any systemic infection within 3 weeks prior to screening.
  9. Female subjects who are pregnant or breast-feeding.
  10. History of clinically significant drug or alcohol abuse in the prior year.
  11. Poorly controlled medical condition, including but not limited to diabetes with documented history of recurrent infections or cerebrovascular accidents (within 3 months).
  12. Subjects who have been on cyclosporine or tacrolimus within 4 weeks of screening.
  13. Subjects who have been on methotrexate within 4 weeks of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421642

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: William J. Sandborn, M.D. Mayo Clinic

Additional Information:
Publications of Results:
Responsible Party: William Sandborn, Mayo Clinic Identifier: NCT00421642     History of Changes
Other Study ID Numbers: 06-002167
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Antirheumatic Agents