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Arthritis, RheumatoidPhase 3NCT00973479

An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy

A Phase 3 study testing Golimumab and methotrexate (MTX) in people with Arthritis, Rheumatoid, run by Centocor, Inc. at 88 sites in 13 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 evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Golimumab and methotrexate (MTX)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
592 participants
Where
88 sitesin 13 countries
Study dates
Sep 2009to Feb 2013
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

  • Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening
  • Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening
  • Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline
  • C-Reactive Protein greater than or equal to 1.0 mg/dL at screening
  • No history of latent or active tuberculosis prior to screening

Who cannot join

  • Other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease
  • Treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent
  • Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent
  • Known allergy to human immunoglobulin proteins or other components of golimumab
  • Received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept

Trial locations and contacts

88 sites in 13 countries.

88 sites in 13 countries

Poland12 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Działdowo

  • Study site

    Elblag

  • Study site

    Katowice

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Sopot

  • Study site

    Szczecin

  • Study site

    Warsaw

  • Study site

    Włoszczowa

  • Study site

    Wroclaw

Other trials in Poland

United States9 sites

  • Study site

    Cincinnati, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Lubbock, Texas

  • Study site

    Miami, Florida

  • Study site

    Moline, Illinois

  • Study site

    Palm Harbor, Florida

  • Study site

    Wheaton, Maryland

  • Study site

    Worcester, Massachusetts

Other trials in United States

Malaysia9 sites

  • Study site

    George Town

  • Study site

    Ipoh

  • Study site

    Johor Bahru

  • Study site

    Kota Kinabalu

  • Study site

    Kuantan

  • Study site

    Kuching

  • Study site

    Precinct 7

  • Study site

    Selangor Darul Ehasan

  • Study site

    Seremban

Other trials in Malaysia

Ukraine9 sites

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Simferopol

  • Study site

    Ternopil

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Hungary7 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Eger

  • Study site

    Győr

  • Study site

    Gyula

  • Study site

    Szombathely

  • Study site

    Veszprém

Other trials in Hungary

Russia7 sites

  • Study site

    Chelyabinsk

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Petrozavodsk

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Yekaterinburg

Other trials in Russia

Argentina6 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Rosario

  • Study site

    San Juan

  • Study site

    San Miguel de Tucumán

  • Study site

    Santa Fe

Other trials in Argentina

South Korea6 sites

  • Study site

    Anyang

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Incheon

  • Study site

    Pusan

  • Study site

    Seoul

Other trials in South Korea

Australia5 sites

  • Study site

    Cairns

  • Study site

    Maroochydore

  • Study site

    Melbourne

  • Study site

    Woodville

  • Study site

    Woolloongabba

Other trials in Australia

Colombia5 sites

  • Study site

    Antioquia

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Cali Valley Del Cauca

  • Study site

    Medellín

Other trials in Colombia

Lithuania5 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

Other trials in Lithuania

Mexico5 sites

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Monterrey

Other trials in Mexico

New Zealand3 sites

  • Study site

    Auckland

  • Study site

    Takapuna Auckland

  • Study site

    Timaru

Other trials in New Zealand

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.

Read the detailed description

This is a randomized (study medication is assigned by chance), double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, 2-arm (2 groups) study of golimumab in participants with active RA despite concurrent MTX therapy. Approximately 564 participants will be randomly allocated to 1 of 2 treatment groups in a 2:1 ratio ie, Group 1(approximately 376 participants will receive golimumab + MTX) and Group 2 (approximately 188 participants will receive MTX + placebo). Total duration of study for each participant is 112 weeks. Safety will be evaluated by assessment of adverse events, tuberculosis testing and blood testing.

Being tested
Golimumab, Placebo, methotrexate (MTX)
Keywords
Arthritis, Rheumatoid, Active rheumatoid arthritis, Golimumab, CNTO148, Anti-TNFalpha monoclonal antibody, Methotrexate, Intravenous
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GolimumabDrug

    Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).

  • PlaceboOther

    Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.

  • methotrexate (MTX)Drug

    Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.

Study groups in NCT00973479
Study groupRoleWhat they receive
Group I: Placebo + Methotrexate (MTX)ExperimentalParticipants will receive placebo at Weeks 0, 4, 12, and 16. Participants will cross over to golimumab at Week 24, and receive administrations at Weeks 24, 28, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will be eligible for early escape (receive golimumab) at Week 16 if they demonstrate a less than 10 percent improvement in both tender and swollen joint count. These participants will receive golimumab at Weeks 16, 20, and every 8 weeks thereafter.
Receives: Drug: Golimumab; Other: Placebo; Drug: methotrexate (MTX)
Group II: Golimumab + Methotrexate (MTX)Placebo comparatorParticipants will receive golimumab at Weeks 0, 4, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Receives: Drug: Golimumab; Other: Placebo; Drug: methotrexate (MTX)

What is being measured

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

  1. Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14

    An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.

    Measured: Week 14

Secondary outcomes (4)

  1. Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14

    DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant's global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a "good response" and a decrease of 0.6-1.2 as a "moderate response".

    Measured: Week 14

  2. Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14

    The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.

    Measured: Week 14

  3. Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24

    An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.

    Measured: Week 24

  4. Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.

    Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.

    Measured: Week 24

Timeline

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

  1. First posted9 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2011
  4. Study completionFeb 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
592 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00973479
Sponsor's protocol ID
CR015784
Other IDs
CNTO148ART3001, 2008-006064-11, 2008
Status last verified
Nov 2013
First submitted
4 Sep 2009
Last updated
25 Dec 2013
Data monitoring committee
Yes

Publications

  • Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.

    PubMed 35313978

  • Lee JB, Broadwell A, Fan Y, Hu C, Adedokun OJ, Chakravarty SD, Zhou H, Xu Z, Leu JH. Population Pharmacokinetic and Exposure-Response Model Simulations: Predicted Exposure and Efficacy for Maintenance Doses of Intravenous Golimumab Every 6 or 8 Weeks in Patients With Moderately to Severely Active Rheumatoid Arthritis. Clin Ther. 2022 Mar;44(3):457-464.e2. doi: 10.1016/j.clinthera.2022.01.015. Epub 2022 Feb 17.

    PubMed 35183373

  • Tesser J, Kafka S, DeHoratius RJ, Xu S, Hsia EC, Turkiewicz A. Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged < 65 years and those >/= 65 years of age. Arthritis Res Ther. 2019 Aug 20;21(1):190. doi: 10.1186/s13075-019-1968-x.

    PubMed 31429794

  • Standish KA, Huang CC, Curran ME, Schork NJ. Comprehensive analysis of treatment response phenotypes in rheumatoid arthritis for pharmacogenetic studies. Arthritis Res Ther. 2017 May 12;19(1):90. doi: 10.1186/s13075-017-1299-8.

    PubMed 28494788

  • Bingham CO 3rd, Mendelsohn AM, Kim L, Xu Z, Leu J, Han C, Lo KH, Westhovens R, Weinblatt ME; GO-FURTHER Investigators. Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1627-36. doi: 10.1002/acr.22556.

    PubMed 25623393

  • Bingham CO 3rd, Weinblatt M, Han C, Gathany TA, Kim L, Lo KH, Baker D, Mendelsohn A, Westhovens R. The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. J Rheumatol. 2014 Jun;41(6):1067-76. doi: 10.3899/jrheum.130864. Epub 2014 May 1.

    PubMed 24786931

  • Weinblatt ME, Westhovens R, Mendelsohn AM, Kim L, Lo KH, Sheng S, Noonan L, Lu J, Xu Z, Leu J, Baker D, Bingham CO; GO-FURTHER investigators. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2014 Dec;73(12):2152-9. doi: 10.1136/annrheumdis-2013-203742. Epub 2013 Sep 3.

    PubMed 24001888

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab and methotrexate (MTX) in people with Arthritis, Rheumatoid, run by Centocor, Inc. at 88 sites in 13 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 5 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Poland, United States, Malaysia, Ukraine, Hungary and 8 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 14 Oct 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?

Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (time frame: Week 14). 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 NCT00973479, which also lists 7 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 25 Dec 2013.

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