Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT01090154
• Date of registration: 15/03/2010
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study UC CIMZIA
• Scientific title: Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study
• Date of first enrolment: December 1, 2010
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01090154
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Scott D Lee, MD
• Affiliation: University of Washington

• Name: Mark T Osterman, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion 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 or PPD and chest X-ray showing no active or latent TB at
screening or within the 6 months prior to the screening visit.

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 creatitine < 1.5 mg/dL

7. Screening stool sample negative for Clostriduim 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 baseline; not allowed during the study

2. Oral 5-ASAs: allowed if at stable dose for at least 2 weeks prior to baseline;
can remain on this stable dose during the study

3. Antibiotics for UC: must be discontinued by 1 month prior to baseline; not
allowed during the study

4. Antidiarrheals: must be discontinued by 2 weeks prior to baseline; 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 baseline (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 baseline

6. 6-Mercaptopurine (6MP)/Azathioprine/Methotrexate: allowed if on for at least 8
weeks, at stable dose for at least 4 weeks prior to baseline; can remain on this
stable dose during the study

7. Anti-TNF therapy: Patients must be naive to CZP. Patients may have had prior
exposure to anti-TNF therapy (e.g., infliximab, adalimumab, golimumab), however
patients who are primary non-responders to more than one anti-TNF medication are
excluded. Patients must have been off their prior anti-TNF medication for at
least 8 weeks prior to baseline.

8. Integrin inhibitor therapy: Patients may have had prior exposure to integrin
inhibitor therapy (e.g., vedolizumab). Patients must have been off of integrin
inhibitor therapy for at least 8 weeks prior to baseline.

9. Cyclosporine: patients previously receiving Cyclosporine for UC must have been
off their prior Cyclosporine therapy for at least 4 weeks prior to baseline.

10. Any other medications for the treatment of Ulcerative colitis or investigational
medications: must be discontinued at least 1 month or 5 half-lives (whichever is
longer) before baseline; not allowed during the study

9. Female subjects of childbearing potential must agree to practice an effective method
of birth control during the study and for 12 weeks after the last dose of study drug.
Acceptable methods include: oral contraceptives, transdermal contraceptives,
injectable contraceptives, implants, intrauterine devices, barrier methods with
spermicide, or surgical sterility.

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). Also, patients found to have
colonic dysplasia at any time during the study will be withdrawn from the study.

4. HIV, chronic or active hepatitis B or C, or patients considered at high risk for
these infections (obtained by history/detailed medical chart review except for
hepatitis B, which will be tested for with blood sample)

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)

11. Lymphoproliferative disorder

SAMPLE SIZE CALCULATION



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Cimzia

Primary Outcome(s)

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]

Secondary Outcome(s)

To determine the change in mean or median serum CRP levels between week 0 and week 54 [Time Frame: Week 54]

To determine the change in mean or median total or partial Mayo score between week 0 and week 54 [Time Frame: Week 54]

To determine all adverse events, serious adverse events, opportunistic infections, and injection site reactions between week 0 and week 64 [Time Frame: Week 64]

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]

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]

To determine the change in mean or median IBDQ or SIBDQ scores between week 0 and week 54 [Time Frame: Week 54]

To determine the corticosteroid-sparing effects of certolizumab pegol over a years treatment time. [Time Frame: Week 54]

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]

To determine the colectomy rate between week 0 and week 54 [Time Frame: Week 54]

Secondary ID(s)

37823

CZP-UC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pennsylvania

UCB Pharma