Open-Label Adalimumab for Ulcerative Colitis Patients

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00421642
First received: January 11, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Ulcerative Colitis
Drug: Adalimumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical remission at each visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Clinical response at each visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Improvement in the mucosal inflammation at week 8 [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Mayo Score [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Ability to taper and discontinue steroids according to the tapering schedule after week 8 [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421642

Locations
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
Investigators
Principal Investigator: William J. Sandborn, M.D. Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: William Sandborn, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00421642     History of Changes
Other Study ID Numbers: 06-002167
Study First Received: January 11, 2007
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014