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Rheumatoid ArthritisPhase 3NCT00264537

A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

A Phase 3 study testing Methotrexate capsules, Golimumab 50 mg injections and Golimumab 100 mg injections in people with Rheumatoid Arthritis, run by Centocor, Inc. at 75 sites in 21 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 the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Methotrexate capsules, Golimumab 50 mg injections and Golimumab 100 mg injections
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
637 participants
Where
75 sitesin 21 countries
Study dates
Dec 2005to Jun 2012
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

  • Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to first administration of study agent
  • Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time)
  • Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a) C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or MRI prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
  • If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent.

Who cannot join

  • Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
  • No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent
  • No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)
  • No history of, or ongoing, chronic or recurrent infectious disease
  • No serious infection within 2 months prior to first administration of study agent.

Trial locations and contacts

75 sites in 21 countries.

75 sites in 21 countries

United States18 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Charlotte, North Carolina

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Dallas, Texas

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Fort Worth, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Lincoln, Nebraska

  • Study site

    Lubbock, Texas

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Moline, Illinois

  • Study site

    Saint Paul, Minnesota

  • Study site

    Springfield, Illinois

  • Study site

    Upland, California

  • Study site

    Witchita, Kansas

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Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Rosario

  • Study site

    S.M. de Tucuman

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Poland5 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Kalisz

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

South Korea4 sites

  • Study site

    Daejeon

  • Study site

    Incheon

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Spain4 sites

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

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Taiwan4 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Taipei

  • Study site

    Tiachung

Other trials in Taiwan

Ukraine4 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kiev

Other trials in Ukraine

Hungary3 sites

  • Study site

    Budapest

  • Study site

    Gyula

  • Study site

    Szombathely

Other trials in Hungary

India3 sites

  • Study site

    Bangalore

  • Study site

    Lucknow Gpo

  • Study site

    Secunderabad

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Malaysia3 sites

  • Study site

    Precinct 7

  • Study site

    Saemban

  • Study site

    Selayang Baru Utara

Other trials in Malaysia

Philippines3 sites

  • Study site

    Cebu

  • Study site

    Manila

  • Study site

    Quezon

Other trials in Philippines

Russia3 sites

  • Study site

    Moscow

  • Study site

    Saratov

  • Study site

    Yaroslavl

Other trials in Russia

Australia2 sites

  • Study site

    Maroochydore

  • Study site

    Melbourne

Other trials in Australia

Belgium2 sites

  • Study site

    Brussels

  • Study site

    Liège

Other trials in Belgium

Canada2 sites

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Chile2 sites

  • Study site

    Rancagua

  • Study site

    Santiago

Other trials in Chile

New Zealand2 sites

  • Study site

    Auckland

  • Study site

    Timaru

Other trials in New Zealand

Thailand2 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

Other trials in Thailand

United Kingdom2 sites

  • Study site

    Leeds

  • Study site

    London

Other trials in United Kingdom

Austria1 site

  • Study site

    Vienna

Other trials in Austria

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.

Read the detailed description

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFa). TNFa is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pain, swelling, and damage from RA. Other marketed drugs that target TNFa (anti-TNFa drugs) have been shown to be effective in reducing the symptoms, signs, and joint damage of RA, but have limitations with respect to safety and ease of use. This is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of a new anti-TNFa drug, golimumab, at 2 doses, injected under the skin every 4 weeks, alone or in combination with methotrexate, compared with methotrexate alone, in subjects with active RA who have not been previously treated with methotrexate. The study hypothesis is that golimumab, alone or in combination with methotrexate, will be more effective in treatment of RA than methotrexate alone, as measured by the American College of Rheumatology (ACR) response criteria and change from baseline in van der Heide Modified Sharp (vdH-S) score, without causing unacceptable significant adverse effects. The ACR response criteria were designed to determine the percentage of subjects who have achieved a certain level of improvement in their signs and symptoms of rheumatoid arthritis. The vdH-S score is a measurement of the amount of joint damage in a subject as seen by x-ray. Other secondary measures of effectiveness include the Health Assessment Questionnaire (HAQ), which is a series of questions that measure a subject's impairment in physical function caused by RA. Golimumab 50 mg or 100 mg, or placebo injections under the skin every 4 weeks until Week52. Methotrexate (MTX) or placebo capsules will be given in addition. At Week52, subjects on MTX alone with joint pain or swelling get golimumab 50mg, and all subjects receive golimumab for about 4 more years.

Being tested
Placebo injections, Placebo capsules, Methotrexate capsules, Golimumab 50 mg injections, Golimumab 100 mg injections
Keywords
Rheumatoid Arthritis, Methotrexate Naïve, subcutaneous injection
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Placebo injectionsDrug

    SC injections

  • Placebo capsulesDrug

    Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).

  • Methotrexate capsulesDrug

    Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.

  • Golimumab 50 mg injectionsBiological

    SC injections

  • Golimumab 100 mg injectionsBiological

    SC injections

Study groups in NCT00264537
Study groupRoleWhat they receive
Group 1: Placebo + MethotrexateExperimentalPlacebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Placebo injections; Drug: Methotrexate capsules; Biological: Golimumab 50 mg injections; Biological: Golimumab 100 mg injections
Group 2: Golimumab 100 mg + PlaceboExperimentalGolimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Placebo capsules; Drug: Methotrexate capsules; Biological: Golimumab 50 mg injections; Biological: Golimumab 100 mg injections
Group 3: Golimumab 50 mg + MethotrexateExperimentalGolimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Methotrexate capsules; Biological: Golimumab 50 mg injections; Biological: Golimumab 100 mg injections
Group 4: Golimumab 100 mg + MethotrexateExperimentalGolimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Methotrexate capsules; Biological: Golimumab 50 mg injections; Biological: Golimumab 100 mg injections

What is being measured

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

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

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

    Measured: Week 24

  2. Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52

    The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.

    Measured: Baseline and Week 52

Secondary outcomes (3)

  1. Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24

    ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.

    Measured: Week 24

  2. Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24

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

    Measured: Week 24

  3. Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline

    The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.

    Measured: Baseline and Week 52

Timeline

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

  1. First posted13 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionApr 2008
  4. Study completionJun 2012

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
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264537
Sponsor's protocol ID
CR006331
Other IDs
GO-BEFORE, C0524T05
Status last verified
Aug 2014
First submitted
11 Dec 2005
Last updated
5 Sep 2014
Data monitoring committee
Yes

Publications

  • Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1.

    PubMed 27803138

  • Baker JF, Conaghan PG, Emery P, Baker DG, Ostergaard M. Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis. Ann Rheum Dis. 2017 Mar;76(3):486-490. doi: 10.1136/annrheumdis-2016-209463. Epub 2016 Jul 18.

    PubMed 27432355

  • Emery P, Fleischmann RM, Hsia EC, Xu S, Zhou Y, Baker D. Efficacy of golimumab plus methotrexate in methotrexate-naive patients with severe active rheumatoid arthritis. Clin Rheumatol. 2014 Sep;33(9):1239-46. doi: 10.1007/s10067-014-2731-y. Epub 2014 Jul 9.

    PubMed 25005327

  • Emery P, Fleischmann RM, Doyle MK, Strusberg I, Durez P, Nash P, Amante E, Churchill M, Park W, Pons-Estel B, Xu W, Xu S, Wu Z, Hsia EC. Golimumab, a human anti-tumor necrosis factor monoclonal antibody, injected subcutaneously every 4 weeks in patients with active rheumatoid arthritis who had never taken methotrexate: 1-year and 2-year clinical, radiologic, and physical function findings of a phase III, multicenter, randomized, double-blind, placebo-controlled study. Arthritis Care Res (Hoboken). 2013 Nov;65(11):1732-42. doi: 10.1002/acr.22072.

    PubMed 23861303

  • Ostergaard M, Emery P, Conaghan PG, Fleischmann R, Hsia EC, Xu W, Rahman MU. Significant improvement in synovitis, osteitis, and bone erosion following golimumab and methotrexate combination therapy as compared with methotrexate alone: a magnetic resonance imaging study of 318 methotrexate-naive rheumatoid arthritis patients. Arthritis Rheum. 2011 Dec;63(12):3712-22. doi: 10.1002/art.30592.

    PubMed 22127693

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate capsules, Golimumab 50 mg injections and Golimumab 100 mg injections in people with Rheumatoid Arthritis, run by Centocor, Inc. at 75 sites in 21 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: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Argentina, Poland, South Korea, Spain and 16 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. 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 13 Jul 2009). 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 Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. 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 NCT00264537, which also lists 5 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 5 Sep 2014.

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