Colitis, UlcerativePhase 2/3NCT00488774
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
A Phase 2/3 study testing Golimumab 1 mg per kg, Golimumab 2 mg per kg and Golimumab 4 mg per kg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 108 sites in 22 countries.
Trial summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Golimumab 1 mg per kg, Golimumab 2 mg per kg and Golimumab 4 mg per kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 108 sitesin 22 countries
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
- Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
- Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
- Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB
Who cannot join
- Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
- Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
- Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
- Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
- Participants with a history of extensive colonic resection
Trial locations and contacts
108 sites in 22 countries.
108 sites in 22 countries
United States36 sites
Study site
Austin, Texas
Study site
Bellevue, Washington
Study site
Bristol, Connecticut
Study site
Burlington, Vermont
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Christiansburg, Virginia
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Dearborn, Michigan
Study site
Fort Dodge, Iowa
Study site
Galveston, Texas
Study site
Germantown, Tennessee
Study site
Great Neck, New York
Study site
Huntington, New York
Study site
Kinston, North Carolina
Study site
Laurel, Maryland
Study site
Lebanon, New Hampshire
Study site
Littleton, Colorado
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Mexico, Missouri
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Richmond, Virginia
Study site
Roseville, California
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Topeka, Kansas
Study site
Troy, Michigan
Study site
Tulsa, Oklahoma
Canada8 sites
Study site
Calgary, Alberta
Study site
Hamilton, Ontario
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Saskatoon, Saskatchewan
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
Hungary8 sites
Study site
Békéscsaba
Study site
Budapest
Study site
Gyõr
Study site
Gyulai Ut 18
Study site
Miskolc
Study site
Pécs
Study site
Székesfehérvár
Study site
Szombathely
Poland6 sites
Study site
Bialystok
Study site
Częstochowa
Study site
Krakow
Study site
Lodz
Study site
Skierniewice
Study site
Sopot
India5 sites
Study site
Hyderabad Andh Prad
Study site
Jaipur
Study site
Lucknow
Study site
Ludhiana
Study site
Pune
Israel5 sites
Study site
Afula
Study site
Hedera
Study site
Jerusalem
Study site
Kfar Saba
Study site
Tel Aviv
Germany4 sites
Study site
Berlin, State of Berlin
Study site
Hamburg, Free and Hanseatic City of Hamburg
Study site
Herne
Study site
Magdeburg
Netherlands4 sites
Study site
Amsterdam
Study site
Groningen
Study site
Leiden
Study site
Rotterdam
Ukraine4 sites
Study site
Donetsk
Study site
Ivano
Study site
Kiev
Study site
Vynnytsya
Lithuania3 sites
Study site
Klaipėda
Study site
Šiauliai
Study site
Vilnius LT
About this study
Official title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
Read the detailed description
This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.
- Conditions
- Colitis, Ulcerative
- Being tested
- Placebo, Golimumab 1 mg per kg, Golimumab 2 mg per kg, Golimumab 4 mg per kg
- Keywords
- Colitis, ulcerative, Golimumab, CNTO 148
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Matching placebo for golimumab, intravenous infusion administered at Week 0
Golimumab 1 mg per kgDrug
Also called CNTO 148
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
Golimumab 2 mg per kgDrug
Also called CNTO 148
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
Golimumab 4 mg per kgDrug
Golimumab 4 mg per kg intravenous (IV) infusion at Week 0
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0 Receives: Other: Placebo |
| Golimumab 1 milligram (mg) per kilogram (kg) | Experimental | Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0. Receives: Drug: Golimumab 1 mg per kg |
| Golimumab 2 mg per kg | Experimental | Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0. Receives: Drug: Golimumab 2 mg per kg |
| Golimumab 4 mg per kg | Experimental | Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0. Receives: Drug: Golimumab 4 mg per kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Measured: Week 6
Secondary outcomes (1)
Number of Participants With Clinical Remission
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Protocol was cancelled by company based on overall efficacy, no safety concern
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488774
- Sponsor's protocol ID
- CR014188
- Other IDs
- C0524T16, 2006-003397-94
- Status last verified
- Apr 2013
- First submitted
- 18 Jun 2007
- Last updated
- 14 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.
PubMed 31982148Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.
PubMed 26119226
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00488774
- Acronym / sponsor ID
- CR014188
- Conditions
- Colitis, Ulcerative
- Keywords
- Colitis, ulcerative, Golimumab, CNTO 148
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol was cancelled by company based on overall efficacy, no safety concern
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Posted 14 Jun 2013
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 assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
Detailed description
This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMatching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0 |
| Golimumab 1 milligram (mg) per kilogram (kg) | Experimental | Drug: Golimumab 1 mg per kgGolimumab 1 mg per kg intravenous (IV) infusion administered at Week 0. |
| Golimumab 2 mg per kg | Experimental | Drug: Golimumab 2 mg per kgGolimumab 2 mg per kg intravenous (IV) infusion administered at Week 0. |
| Golimumab 4 mg per kg | Experimental | Drug: Golimumab 4 mg per kgGolimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
- Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
- Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
- Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB
Key exclusion criteria (5 listed)
- Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
- Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
- Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
- Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
- Participants with a history of extensive colonic resection
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 |
|---|---|---|
| PlaceboMatching placebo for golimumab, intravenous infusion administered at Week 0 | Other | Placebo |
| Golimumab 1 mg per kgAlso: CNTO 148Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0 | Drug | Golimumab 1 milligram (mg) per kilogram (kg) |
| Golimumab 2 mg per kgAlso: CNTO 148Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0 | Drug | Golimumab 2 mg per kg |
| Golimumab 4 mg per kgGolimumab 4 mg per kg intravenous (IV) infusion at Week 0 | Drug | Golimumab 4 mg per kg |
Primary outcome
Number of Participants With Clinical Response
Time frame: Week 6
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
1 secondary outcome
Number of Participants With Clinical Remission
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31982148Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.
- Derived from this study: PubMed 26119226Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
108 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Golimumab 1 mg per kg, Golimumab 2 mg per kg and Golimumab 4 mg per kg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 108 sites in 22 countries.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in United States, Canada, Hungary, Poland, India and 17 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Response (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488774, which also lists 2 linked publications.
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 Jun 2013.