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Trial record 20 of 201 for:    Open Studies | "Colitis, Ulcerative"

Study of Cimzia for the Treatment of Ulcerative Colitis (UC CIMZIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
UCB Pharma
University of Pennsylvania
Information provided by (Responsible Party):
Scott Lee, University of Washington
ClinicalTrials.gov Identifier:
NCT01090154
First received: March 15, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Drug: Cimzia
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To determine the proportion of patients achieving clinical response determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Clinical response is defined as a decrease in the Total Mayo Score of at least 3 points by Week 14 compared to Week 0.


Secondary Outcome Measures:
  • To determine the proportion of patients achieving clinical remission determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Clinical remission is defined as a total Mayo score of less than or equal to 2 with no individual subscore greater than 1 at Week 14 compared to Week 0.

  • To determine the proportion of patients achieving clinical response or clinical remission at week 54 per the same criteria as listed above. [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • To determine the proportion of patients achieving mucosal healing at weeks 14 and 54 defined as a Mayo endoscopic subscore less than 2. [ Time Frame: Week 14/54 ] [ Designated as safety issue: No ]
  • To determine the corticosteroid-sparing effects of certolizumab pegol over a years treatment time. [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    To determine if patients are able to remain off steroids and maintain response or remission with certolizumab pegol alone and not necessitate concomitant treatment with steroids.

  • To determine the colectomy rate between week 0 and week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • To determine the change in mean or median total or partial Mayo score between week 0 and week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • To determine the change in mean or median serum CRP levels between week 0 and week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • To determine the change in mean or median IBDQ or SIBDQ scores between week 0 and week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • To determine all adverse events, serious adverse events, opportunistic infections, and injection site reactions between week 0 and week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cimzia
Treatment with open label Cimzia (certolizumab pegol)
Drug: Cimzia
Cimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing.
Other Name: certolizumab pegol

Detailed Description:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often results in significant morbidity as well as impairment in quality of life. Cimzia (certolizumab pegol), an inhibitor of tumor necrosis factor-alpha, is an effective treatment for Crohn's disease, a similar inflammatory bowel disease. The aims of this study are to determine if Cimzia is effective for both the induction and maintenance of response/remission for the patients with moderate to severe Ulcerative colitis.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18-75 years
  2. Established diagnosis of UC (by routine clinical, radiologic, endoscopic, and histologic criteria) of at least 3 months duration
  3. Moderate to severe active disease, defined by Mayo score > 6 with endoscopic subscore > 2
  4. Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent
  5. No history of prior tuberculosis TB), no signs or symptoms of active TB, and negative Quantiferon gold test and chest X-ray showing no active or latent TB at screening
  6. Screening blood tests must meet the following criteria: white blood cell count > 3000/µL (with neutrophils > 1500/µL and lymphocytes > 500/µL), hemoglobin > 8 g/dL, platelet count > 100,000/µL, liver function tests < 3 times the upper limit of normal, serum creatine < 1.5 mg/dL
  7. Screening stool sample negative for Clostridium difficile, ova & parasites, and aerobic pathogens, including Aeromonas, Plesiomonas, Salmonella, Shigella, Yersinia, Campylobacter, and E. coli spp.
  8. Medication use must meet the following criteria:

    1. Rectally administered topical 5-aminosalicylates (5-ASAs)/corticosteroids: must be discontinued by 1 month prior to screening; not allowed during the study
    2. Oral 5-ASAs: allowed if at stable dose for at least 2 weeks prior to screening; can remain on this stable dose during the study
    3. Antibiotics for UC: must be discontinued by 1 month prior to screening; not allowed during the study
    4. Antidiarrheals: must be discontinued by 2 weeks prior to screening; not allowed during the study
    5. Corticosteroids: allowed if at Prednisone dose equivalent of 20 mg/d or less, stable for 2 weeks prior to screening (dose/taper during study discussed below); budesonide is allowed at a dose less than or equal to 9 mg/day if at stable dose for 2 weeks prior to screening
    6. 6-Mercaptopurine (6MP)/Azathioprine/Methotrexate: allowed if on for at least 8 weeks, at stable dose for at least 4 weeks prior to screening; can remain on this stable dose during the study
    7. Anti-TNF therapy: patients must be naive to CZP; patients must be either naive to anti-TNF therapy or have lost response or become intolerant to at most one prior anti-TNF medication (infliximab or adalimumab, but not both) and must have been off their prior anti-TNF medication for at least 8 weeks prior to screening; primary nonresponders to anti-TNF therapy are excluded from the study
    8. Cyclosporine: patients previously receiving Cyclosporine for UC are excluded from the study
    9. Any other or investigational medications: must be discontinued at least 1 month or 5 half-lives (whichever is longer) before screening; not allowed during the study

Exclusion Criteria:

  1. Diagnosis of Crohn's disease or indeterminate colitis, or clinical findings suggestive of Crohn's disease
  2. Fulminant disease, toxic megacolon, or anticipated imminent colectomy
  3. Presence of ileal pouch or ostomy
  4. Pregnancy, desire to become pregnant during the following 18 months, or breast feeding
  5. Surgery of any kind within 2 months of screening or anticipated surgery of any kind during the study
  6. Anticipated imminent hospitalization for any medical conditions
  7. Active ongoing infection of any kind
  8. Current use of total parenteral nutrition
  9. History of:

    1. Congestive heart failure or significant coronary artery disease (including myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within 6 months of screening)
    2. Cancer
    3. Colonic dysplasia (except sporadic adenomas)
    4. HIV, chronic or active hepatitis B or C, or patients considered at high risk for these infections
    5. Prior opportunistic infection within 6 months of screening or prior opportunistic infection while on other anti-TNF therapy
    6. Hepatic disease (cirrhosis, chronic active hepatitis, or LFT abnormalities as above)
    7. Renal insufficiency (see above)
    8. Clinically important pulmonary disease (as determined subjectively)
    9. Demyelinating disease
    10. Organ transplantation, including bone marrow (except corneal)
  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: NCT01090154

Contacts
Contact: Chelle L Wheat, MPH 206-221-3338 chellew@medicine.washington.edu
Contact: Elisa Beebe, BS 206-543-3500 ebeebe@medicine.washington.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sue Parrott    215-662-8919      
Principal Investigator: Mark T Osterman, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Chelle L Wheat, MPH    206-221-3338    chellew@medicine.washington.edu   
Contact: Elisa Beebe, BS    206-543-3500    ebeebe@medicine.washington.edu   
Principal Investigator: Scott D Lee, MD         
Sponsors and Collaborators
Scott Lee
UCB Pharma
University of Pennsylvania
Investigators
Principal Investigator: Scott D Lee, MD University of Washington
Principal Investigator: Mark T Osterman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Scott Lee, Associate Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT01090154     History of Changes
Other Study ID Numbers: 37823-B, CZP-UC-001
Study First Received: March 15, 2010
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Ulcerative colitis
UC
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis, Ulcerative
Colitis
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014