Ulcerative ColitisPhase 2UC CIMZIANCT01090154
Study of Cimzia for the Treatment of Ulcerative Colitis
A Phase 2 study testing Cimzia in people with Ulcerative Colitis, run by University of Washington at 2 sites in United States.
Trial summary
The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Cimzia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2010to 10 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years
- Established diagnosis of UC (by routine clinical, radiologic, endoscopic, and histologic criteria) of at least 3 months duration
- Moderate to severe active disease, defined by Mayo score > 6 with endoscopic subscore > 2
- Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent
- 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.
- 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
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- Screening stool sample negative for Clostriduim difficile, ova \& parasites, and aerobic pathogens, including Aeromonas, Plesiomonas, Salmonella, Shigella, Yersinia, Campylobacter, and E. coli spp.
- Medication use must meet the following criteria:
- Rectally administered topical 5-aminosalicylates (5-ASAs)/corticosteroids: must be discontinued by 1 month prior to baseline; not allowed during the study
- 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
- Antibiotics for UC: must be discontinued by 1 month prior to baseline; not allowed during the study
- Antidiarrheals: must be discontinued by 2 weeks prior to baseline; not allowed during the study
- 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-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
- 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.
- 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.
- Cyclosporine: patients previously receiving Cyclosporine for UC must have been off their prior Cyclosporine therapy for at least 4 weeks prior to baseline.
- 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
- 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.
Who cannot join
- Diagnosis of Crohn's disease or indeterminate colitis, or clinical findings suggestive of Crohn's disease
- Fulminant disease, toxic megacolon, or anticipated imminent colectomy
- Presence of ileal pouch or ostomy
- Pregnancy, desire to become pregnant during the following 18 months, or breast feeding
- Surgery of any kind within 2 months of screening or anticipated surgery of any kind during the study
- Anticipated imminent hospitalization for any medical conditions
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- Active ongoing infection of any kind
- Current use of total parenteral nutrition
- History of:
- Congestive heart failure or significant coronary artery disease (including myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within 6 months of screening)
- Cancer
- Colonic dysplasia (except sporadic adenomas). Also, patients found to have colonic dysplasia at any time during the study will be withdrawn from the study.
- 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)
- Prior opportunistic infection within 6 months of screening or prior opportunistic infection while on other anti-TNF therapy
- Hepatic disease (cirrhosis, chronic active hepatitis, or LFT abnormalities as above)
- Renal insufficiency (see above)
- Clinically important pulmonary disease (as determined subjectively)
- Demyelinating disease
- Organ transplantation, including bone marrow (except corneal)
- Lymphoproliferative disorder
- SAMPLE SIZE CALCULATION
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Washington
Seattle, Washington, 98195
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Cimzia
- Keywords
- Ulcerative colitis, UC, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CimziaDrug
Also called certolizumab pegol
Cimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing.
| Study group | Role | What they receive |
|---|---|---|
| Cimzia | Experimental | Treatment with open label Cimzia (certolizumab pegol) Receives: Drug: Cimzia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Clinical response is defined as a decrease in the Total Mayo Score of at least 3 points by Week 14 compared to Week 0.
Measured: Week 14
Secondary outcomes (9)
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.
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.
Measured: Week 14
To determine the proportion of patients achieving clinical response or clinical remission at week 54 per the same criteria as listed above.
Measured: 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.
Measured: Week 14/54
To determine the corticosteroid-sparing effects of certolizumab pegol over a years treatment time.
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.
Measured: Week 54
To determine the colectomy rate between week 0 and week 54
Measured: Week 54
To determine the change in mean or median total or partial Mayo score between week 0 and week 54
Measured: Week 54
To determine the change in mean or median serum CRP levels between week 0 and week 54
Measured: Week 54
To determine the change in mean or median IBDQ or SIBDQ scores between week 0 and week 54
Measured: Week 54
To determine all adverse events, serious adverse events, opportunistic infections, and injection site reactions between week 0 and week 64
Measured: Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study start1 Dec 2010
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma, University of Pennsylvania
- Responsible party
- Principal investigator, Scott Lee, University of Washington
- Investigators
- Scott D Lee, MD, Principal investigator, University of WashingtonMark T Osterman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090154
- Sponsor's protocol ID
- 37823
- Other IDs
- CZP-UC-001
- Acronym
- UC CIMZIA
- Status last verified
- Dec 2021
- First submitted
- 15 Mar 2010
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study
- ClinicalTrials.gov ID
- NCT01090154
- Acronym / sponsor ID
- UC CIMZIA / 37823
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, UC, Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- UCB Pharma, University of Pennsylvania
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cimzia | Experimental | Drug: CimziaTreatment with open label Cimzia (certolizumab pegol) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adults aged 18-75 years
- Established diagnosis of UC (by routine clinical, radiologic, endoscopic, and histologic criteria) of at least 3 months duration
- Moderate to severe active disease, defined by Mayo score > 6 with endoscopic subscore > 2
- Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent
- 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.
Key exclusion criteria (21 listed)
- Diagnosis of Crohn's disease or indeterminate colitis, or clinical findings suggestive of Crohn's disease
- Fulminant disease, toxic megacolon, or anticipated imminent colectomy
- Presence of ileal pouch or ostomy
- Pregnancy, desire to become pregnant during the following 18 months, or breast feeding
- Surgery of any kind within 2 months of screening or anticipated surgery of any kind during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CimziaAlso: certolizumab pegolCimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing. | Drug | Cimzia |
Primary outcome
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
Clinical response is defined as a decrease in the Total Mayo Score of at least 3 points by Week 14 compared to Week 0.
9 secondary outcomes
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 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 corticosteroid-sparing effects of certolizumab pegol over a years treatment time.
Time frame: Week 54
To determine the colectomy rate 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 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 IBDQ or SIBDQ scores 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Lee, MD principal investigator
University of Washington
Mark T Osterman, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cimzia in people with Ulcerative Colitis, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.