AzTrials
AzTrials

Colitis, UlcerativePhase 3NCT00488631

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

A Phase 3 study testing Golimumab 50 mg, Golimumab 100 mg and Golimumab 200 mg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 297 sites in 26 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 safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy. 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 50 mg, Golimumab 100 mg and Golimumab 200 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,228 participants
Where
297 sitesin 26 countries
Study dates
Sep 2007to Feb 2015
Phase
Phase 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 who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
  • Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)

Who cannot join

  • Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
  • Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
  • Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
  • Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
  • Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)

Trial locations and contacts

297 sites in 26 countries.

297 sites in 26 countries

United States96 sites

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bellevue, Washington

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boone, North Carolina

  • Study site

    Bristol, Connecticut

  • Study site

    Burlington, Vermont

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Christiansburg, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Colombus, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Dearborn, Michigan

  • Study site

    Decatur, Georgia

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Fairfax, Virginia

  • Study site

    Fargo, North Dakota

  • Study site

    Fort Dodge, Iowa

  • Study site

    Gainesville, Florida

  • Study site

    Galveston, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Great Neck, New York

  • Study site

    Hagerstown, Maryland

  • Study site

    Harrisburg, North Carolina

  • Study site

    Hialeah, Florida

  • Study site

    Hollywood, Florida

  • Study site

    Hollywood, Maryland

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Jacksonville, Florida

  • Study site

    Kinston, North Carolina

  • Study site

    Lakewood, Colorado

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurel, Maryland

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lexington, Kentucky

  • Study site

    Limerick, Pennsylvania

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Logan, Utah

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Merced, California

  • 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

    North Miami Beach, Florida

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Pascagoula, Mississippi

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plymouth, Minnesota

  • 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

    Seattle, Washington

  • Study site

    Snellville, Georgia

  • Study site

    Spokane, Washington

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tupelo, Mississippi

  • Study site

    Urbana, Missouri

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    Zephyrhills, Florida

Other trials in United States

Hungary18 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Dunaújváros

  • Study site

    Gyõr

  • Study site

    Gyula

  • Study site

    Gyulai Ut 18

  • Study site

    Miskolc

  • Study site

    Mosonmagyaróvár

  • Study site

    Pécs

  • Study site

    Siófok

  • Study site

    Sopron

  • Study site

    Szeged

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

  • Study site

    Szombathely

  • Study site

    Veszprém

  • Study site

    Zalaegerszeg

Other trials in Hungary

Germany17 sites

  • Study site

    Aachen

  • Study site

    Berlin

  • Study site

    Berlin Be

  • Study site

    Bochum

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Herne

  • Study site

    Jena

  • Study site

    Kiel

  • Study site

    Magdeburg

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

  • Study site

    Neustadt

  • Study site

    Stade

Other trials in Germany

Canada15 sites

  • Study site

    Barrie, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Chatham, Ontario

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto

  • Study site

    Vancouver, British Columbia

  • Study site

    Vaughan, Ontario

  • Study site

    Victoria, British Columbia

  • Study site

    Windsor

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

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

Poland14 sites

  • Study site

    Bialystok

  • 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

    Skierniewice

  • Study site

    Sopot

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

Other trials in Poland

Australia13 sites

  • Study site

    Adelaide

  • Study site

    Bankstown

  • Study site

    Box Hill

  • Study site

    Brisbane

  • Study site

    Cairns

  • Study site

    Fitzroy

  • Study site

    Fremantle

  • Study site

    Herston

  • Study site

    Launceston

  • Study site

    Malvern

  • Study site

    Parkville

  • Study site

    Prahran

  • Study site

    Westmead

Other trials in Australia

Israel13 sites

  • Study site

    Afula

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Hedera

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Kiryat Bialik

  • Study site

    Nazareth

  • Study site

    Petah-Tikv

  • Study site

    Rehovot

  • Study site

    Tel Aviv

  • Study site

    Tel HaShomer

Other trials in Israel

India11 sites

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Hyderabad

  • Study site

    Hyderabad Andh Prad

  • Study site

    Jaipur

  • Study site

    Kārnād

  • Study site

    Lucknow Gpo

  • Study site

    Ludhiana

  • Study site

    New Delhi

  • Study site

    Pune

  • Study site

    Vishakapatanam

Other trials in India

Ukraine10 sites

  • Study site

    Donetsk

  • Study site

    Ivano

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Poltava

  • Study site

    Simferopol

  • Study site

    Vinnitsa

  • Study site

    Zhaporozhia 69104

Other trials in Ukraine

France8 sites

  • Study site

    Amiens Cedex 1 80

  • Study site

    Bordeaux

  • Study site

    Clichy

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Rouen

Other trials in France

Belgium6 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Roeselare

Other trials in Belgium

Netherlands6 sites

  • Study site

    Amsterdam

  • Study site

    Ede Gld

  • Study site

    Groningen

  • Study site

    Leiden

  • Study site

    Nieuwegein

  • Study site

    Rotterdam

Other trials in Netherlands

Russia6 sites

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Saint Petersburg

  • Study site

    Smolensk

  • Study site

    Yaroslavl

Other trials in Russia

Slovakia6 sites

  • Study site

    Bratislava

  • Study site

    Martin

  • Study site

    Nitra

  • Study site

    Nové Mesto nad Váhom

  • Study site

    Prešov

  • Study site

    Trnava

Other trials in Slovakia

Bulgaria5 sites

  • Study site

    Bulgaria

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

Lithuania5 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

  • Study site

    Vilnius Lt

Other trials in Lithuania

New Zealand5 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Hamilton

  • Study site

    Hastings

Other trials in New Zealand

Romania5 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Iași

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

South Africa5 sites

  • Study site

    Cape Town

  • Study site

    Cape Town West Cape

  • Study site

    Durban

  • Study site

    Plumstead West Cape

  • Study site

    Pretoria Gauteng

Other trials in South Africa

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

Latvia3 sites

  • Study site

    Balvi

  • Study site

    Daugavpils

  • Study site

    Riga

Other trials in Latvia

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Niš

  • Study site

    Zemun

Other trials in Serbia

Austria2 sites

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Sweden2 sites

  • Study site

    Gothenburg

  • Study site

    Stockholm

Other trials in Sweden

About this study

Official title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

Read the detailed description

This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.

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

    Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

  • Golimumab 50 mgBiological

    Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

  • Golimumab 100 mgBiological

    Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.

  • Golimumab 200 mgBiological

    Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.

Study groups in NCT00488631
Study groupRoleWhat they receive
Golimumab induction responders (GLM-I-Rsp)-Placebo MaintenancePlacebo comparatorParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
Receives: Biological: Placebo; Biological: Golimumab 100 mg
GLM-I-Rsp-Golimumab 50 mg MaintenanceExperimentalParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
Receives: Biological: Golimumab 50 mg; Biological: Golimumab 100 mg
GLM-I-Rsp-Golimumab 100 mg MaintenanceExperimentalParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52.
Receives: Biological: Golimumab 100 mg; Biological: Golimumab 200 mg
Placebo induction responders (PBO-I-Rsp)-Placebo MaintenancePlacebo comparatorParticipants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
Receives: Biological: Placebo; Biological: Golimumab 100 mg
PBO-I-nonRsp-Golimumab 100 mg MaintenanceExperimentalParticipants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Receives: Biological: Golimumab 100 mg
GLM-I-nonRsp-Golimumab 100 mg MaintenanceExperimentalParticipants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Receives: Biological: Golimumab 100 mg

What is being measured

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

  1. Number of Participants in Clinical Response Through Week 54

    Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.

    Measured: Induction Baseline, Week 0 through Week 54

Secondary outcomes (4)

  1. Number of Participants With Clinical Remission at Both Week 30 and Week 54

    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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.

    Measured: Week 30 and Week 54

  2. Number of Participants With Mucosal Healing at Both Week 30 and Week 54

    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). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.

    Measured: Week 30 and Week 54

  3. Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study

    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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.

    Measured: Week 30 and Week 54

  4. Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study

    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 54

Timeline

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

  1. First posted20 Jun 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2011
  4. Study completionFeb 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00488631
Sponsor's protocol ID
CR014179
Other IDs
2006-003399-37, C0524T18
Status last verified
Mar 2016
First submitted
18 Jun 2007
Last updated
26 Apr 2016
Data monitoring committee
Yes

Publications

  • Weinstein CLJ, Meehan AG, Govoni M, Lin J, Reinisch W. Low Occurrence of Colectomy With Long-Term (up to 4 Years) Golimumab Treatment in Patients With Moderate-to-Severe Active Ulcerative Colitis: Data From the PURSUIT Maintenance and Long-Term Extension Studies. Crohns Colitis 360. 2023 Aug 26;5(3):otad044. doi: 10.1093/crocol/otad044. eCollection 2023 Jul.

    PubMed 37691729

  • Perrig K, Krupka N, Jordi SBU, Rossel JB, Biedermann L, Greuter T, Schreiner P, Vavricka SR, Juillerat P, Burri E, Zimmermann D, Maillard MH, Sulz MC, Brand S, Rogler G, Misselwitz B. Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Ther Adv Gastroenterol. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.

    PubMed 35154389

  • 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

  • Philip G, Cornillie F, Adedokun JO, Melsheimer R, Rutgeerts P, Colombel JF, Marano C. Early Dose Optimisation of Golimumab in Nonresponders to Induction Treatment for Ulcerative Colitis Is Effective and Supported by Pharmacokinetic Data. J Crohns Colitis. 2019 Sep 27;13(10):1257-1264. doi: 10.1093/ecco-jcc/jjz052.

    PubMed 30847474

  • Reinisch W, Gibson PR, Sandborn WJ, Feagan BG, Strauss R, Johanns J, Padgett L, Adedokun OJ, Colombel JF, Collins J, Rutgeerts P, Tarabar D, Marano C. Long-Term Benefit of Golimumab for Patients with Moderately to Severely Active Ulcerative Colitis: Results from the PURSUIT-Maintenance Extension. J Crohns Colitis. 2018 Aug 29;12(9):1053-1066. doi: 10.1093/ecco-jcc/jjy079.

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  • 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, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab 50 mg, Golimumab 100 mg and Golimumab 200 mg in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 297 sites in 26 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 2 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 297 sites in United States, Hungary, Germany, Canada, Japan and 21 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 phase mean?

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 11 Nov 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 in Clinical Response Through Week 54 (time frame: Induction Baseline, Week 0 through Week 54). 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 NCT00488631, which also lists 6 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 26 Apr 2016.

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