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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

March 15, 2010
June 13, 2012
October 2010
December 2013   (final data collection date for primary outcome measure)
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.
To determine the proportion of patients achieving clinical response at week 14 defined as a decrease from week 0 in the total Mayo score of greater than or equal to 3 points (or greater than 30%) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01090154 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the proportion of patients achieving clinical remission at Week 14 defined as a total Mayo score of less than or equal to 2 with no individual subscore greater than 1. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • 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 [ 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 ]
Not Provided
Not Provided
 
Study of Cimzia for the Treatment of Ulcerative Colitis
Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
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
Experimental: Cimzia
Treatment with open label Cimzia (certolizumab pegol)
Intervention: Drug: Cimzia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact: Chelle L Wheat, MPH 206-221-3338 chellew@medicine.washington.edu
Contact: Elisa Beebe, BS 206-543-3500 ebeebe@medicine.washington.edu
United States
 
NCT01090154
37823-B, CZP-UC-001
Yes
Scott Lee, University of Washington
Scott Lee
  • UCB Pharma
  • University of Pennsylvania
Principal Investigator: Scott D Lee, MD University of Washington
Principal Investigator: Mark T Osterman, MD University of Pennsylvania
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP