AzTrials
AzTrials

Colitis, UlcerativePhase 2/3NCT00487539

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 study testing Golimumab 100 mg, Golimumab 200 mg and Golimumab 400 mg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 200 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC). 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 100 mg, Golimumab 200 mg and Golimumab 400 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,065 participants
Where
200 sitesin 25 countries
Study dates
Aug 2007to Oct 2010
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, oral corticosteroids, 6-mercaptopurine and azathioprine
  • 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 tuberculosis
  • Participants with negative stool test for enteric (by way of the intestines) pathogens

Who cannot join

  • Participants with prior 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 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

200 sites in 25 countries.

200 sites in 25 countries

United States58 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colombus, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Fairfax, Virginia

  • Study site

    Fargo, North Dakota

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Golden, Colorado

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Limerick, Pennsylvania

  • Study site

    Little Rock, Arkansas

  • Study site

    Logan, Utah

  • Study site

    Madison, Wisconsin

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Monroe, Louisiana

  • Study site

    Morganton, North Carolina

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Bern, North Carolina

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Norman, Oklahoma

  • Study site

    Ogden, Utah

  • Study site

    Pascagoula, Mississippi

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Pratt, Kansas

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Roseville, California

  • Study site

    San Diego, California

  • Study site

    Savannah, Georgia

  • Study site

    Spokane, Washington

  • Study site

    Sugar Land, Texas

  • Study site

    Tacoma, Washington

  • Study site

    Troy, Michigan

  • Study site

    Tupelo, Mississippi

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

  • Study site

    Zephyrhills, Florida

Other trials in United States

Japan15 sites

  • Study site

    Bunkyō City

  • Study site

    Chikushinoshi

  • Study site

    Fukuoka

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Kurashiki

  • Study site

    Kurume

  • Study site

    Nagoya

  • Study site

    Nishinomiya

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Tokyo

  • Study site

    Yokkaichi

Other trials in Japan

Poland12 sites

  • Study site

    Bydgoszcz

  • Study site

    Częstochowa

  • Study site

    Elblag

  • Study site

    Gdansk

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Opole

  • Study site

    Sopot

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

Other trials in Poland

Germany11 sites

  • Study site

    Berlin

  • Study site

    Berlin Be

  • Study site

    Bochum

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Haßloch

  • Study site

    Kiel

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

  • Study site

    Stade

Other trials in Germany

Hungary11 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Dunaújváros

  • Study site

    Gyulai Ut 18

  • Study site

    Mosonmagyaróvár

  • Study site

    Sopron

  • Study site

    Szeged

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

  • Study site

    Veszprém

Other trials in Hungary

Israel9 sites

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Nazareth

  • Study site

    Petah-Tikv

  • Study site

    Rehovot

  • Study site

    Tel Aviv

Other trials in Israel

Australia8 sites

  • Study site

    Bankstown

  • Study site

    Box Hill

  • Study site

    Fitzroy

  • Study site

    Herston

  • Study site

    Launceston

  • Study site

    Parkville

  • Study site

    Prahran

  • Study site

    Westmead

Other trials in Australia

Canada8 sites

  • Study site

    Barrie, Ontario

  • Study site

    Chatham, Ontario

  • Study site

    London, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    T2n

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Windsor

Other trials in Canada

India8 sites

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Hyderabad

  • Study site

    Hyderabad Andh Prad

  • Study site

    Kārnād

  • Study site

    New Delhi

  • Study site

    Pune

  • Study site

    Vishakapatanam

Other trials in India

Ukraine6 sites

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Simferopol

  • Study site

    Vynnytsya

  • Study site

    Zhaporozhia 69104

Other trials in Ukraine

Belgium5 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Roeselare

Other trials in Belgium

France5 sites

  • Study site

    Amiens Cedex 1 80

  • Study site

    Bordeaux

  • Study site

    Lille

  • Study site

    Nice

  • Study site

    Paris

Other trials in France

Romania5 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Iași

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Russia5 sites

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Saint Petersburg

  • Study site

    Yaroslavl

Other trials in Russia

Slovakia5 sites

  • Study site

    Bratislava

  • Study site

    Martin

  • Study site

    Nitra

  • Study site

    Nové Mesto nad Váhom

  • Study site

    Prešov

Other trials in Slovakia

Czechia4 sites

  • Study site

    Èeské Budìjovice 1

  • Study site

    Hradec Králové

  • Study site

    Litoměřice

  • Study site

    Ostrava

Other trials in Czechia

Denmark4 sites

  • Study site

    Aalborg

  • Study site

    Aarhus C

  • Study site

    Hvidovre

  • Study site

    Odense C

Other trials in Denmark

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Ede Gld

  • Study site

    Groningen

  • Study site

    Leiden

Other trials in Netherlands

South Africa4 sites

  • Study site

    Cape Town

  • Study site

    Cape Town West Cape

  • Study site

    Marianhill Kz-Natal

  • Study site

    Pretoria Gauteng

Other trials in South Africa

Bulgaria3 sites

  • Study site

    Pleven

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

New Zealand3 sites

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Hamilton

Other trials in New Zealand

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Niš

  • Study site

    Zemun

Other trials in Serbia

Lithuania2 sites

  • Study site

    Kaunas

  • Study site

    Vilnius

Other trials in Lithuania

Austria1 site

  • Study site

    Vienna

Other trials in Austria

Sweden1 site

  • Study site

    Stockholm

Other trials in Sweden

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 Subcutaneously, 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 ulcerative colitis (UC).

Read the detailed description

This is a multi-center (conducted in more than one center), randomized (study medication assigned by chance), double-blind (neither the physician nor the participant know about the study medication), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study to evaluate the safety and efficacy of golimumab in participants with moderately to severely active UC. There are 2 parts in this study. Part 1 is "Phase 2 dose-ranging" portion of study. Participants enrolled in Part 1, will receive subcutaneous (under the skin by way of a needle) injections of placebo, golimumab 100 milligram (mg), 200 mg, or 400 mg at Week 0, followed by subcutaneous injections of placebo, golimumab 50 mg, 100 mg, or 200 mg respectively at Week 2. Part 2 is "Phase 3 dose-confirming" portion of study and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo. 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 16 weeks after last administration of study agent. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks after last administration of study agent for participants who do not enter the 1-year golimumab maintenance study. Efficacy of the participants will primarily be evaluated by clinical response at Week 6. Participants' safety will be monitored throughout the study.

Being tested
Placebo, Golimumab 100 mg, Golimumab 200 mg, Golimumab 400 mg, Golimumab 50 mg
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.

  • PlaceboBiological

    Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.

  • Golimumab 100 mgBiological

    Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.

  • Golimumab 200 mgBiological

    Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.

  • Golimumab 400 mgBiological

    Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group.

  • Golimumab 50 mgBiological

    Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group.

Study groups in NCT00487539
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Receives: Biological: Placebo
Golimumab 100 mg -> 50 mgExperimentalGolimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
Receives: Biological: Golimumab 100 mg; Biological: Golimumab 50 mg
Golimumab 200 mg -> 100 mgExperimentalGolimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
Receives: Biological: Golimumab 100 mg; Biological: Golimumab 200 mg
Golimumab 400 mg -> 200 mgExperimentalGolimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.
Receives: Biological: Golimumab 200 mg; Biological: Golimumab 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Clinical Response at 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 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: Baseline, Week 6

Secondary outcomes (3)

  1. Number of Participants With Clinical Remission at Week 6

    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 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

  2. Number of Participants With Mucosal Healing at Week 6

    Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).

    Measured: Week 6

  3. Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6

    The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,065 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00487539
Sponsor's protocol ID
CR014176
Other IDs
C0524T17, 2006-003398-28, NCT00487539
Status last verified
Jan 2014
First submitted
14 Jun 2007
Last updated
17 Feb 2014
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 31982148

  • Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.

    PubMed 30721964

  • Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.

    PubMed 23735746

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Golimumab 100 mg, Golimumab 200 mg and Golimumab 400 mg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 200 sites in 25 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 6 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: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States, Japan, Poland, Germany, Hungary and 20 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 17 Feb 2014). 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 at Week 6 (time frame: Baseline, 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 NCT00487539, which also lists 3 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 17 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in