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Arthritis, RheumatoidPhase 3NCT00299546

A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)

A Phase 3 study testing Golimumab 50 mg and Golimumab 100 mg in people with Arthritis, Rheumatoid, run by Centocor, Inc. at 77 sites in 10 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab). 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 50 mg and Golimumab 100 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
461 participants
Where
77 sitesin 10 countries
Study dates
Feb 2006to May 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

  • Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
  • 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
  • Must have been previously treated with at least one dose of etanercept, adalimumab, or infliximab
  • If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have tolerated these agents for at least 12 weeks and be on a stable dose for at least 4 weeks prior to the first administration of study agent
  • If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks prior to the first administration of study agent
  • 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
  • Are considered eligible according to specified tuberculosis (TB) screening criteria.

Who cannot join

  • Patients cannot have other inflammatory diseases other than RA that might interfere with the evaluation of the benefit of golimumab therapy
  • No history of treatment with natalizumab, rituximab or cytotoxic agents
  • No history of demyelinating diseases such as multiple sclerosis or optic neuritis or of concurrent congestive heart failure (CHF), lymphoproliferative disease, known malignancy or history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
  • 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

77 sites in 10 countries.

77 sites in 10 countries

United States40 sites

  • Study site

    Arlington, Virginia

  • Study site

    Aventura, Florida

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Brookfield, Wisconsin

  • Study site

    Cedar Rapids, Iowa

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Fort Worth, Texas

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Knoxville, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Largo, Florida

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Mayfield, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Palm Harbor, Florida

  • Study site

    Paradise Valley, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Racine, Wisconsin

  • Study site

    Rochester, Minnesota

  • Study site

    Santa Monica, California

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Syracuse, New York

  • Study site

    Tamarac, Florida

  • Study site

    Torrance, California

  • Study site

    Trumbull, Connecticut

  • Study site

    Upland, California

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Wilmington, North Carolina

  • Study site

    Witchita, Kansas

Other trials in United States

Canada9 sites

  • Study site

    Claire

  • Study site

    Kitchener, Ontario

  • Study site

    Newmarket, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Germany9 sites

  • Study site

    Baden-Baden

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Erlangen

  • Study site

    Hamburg

  • Study site

    Herne

  • Study site

    München

  • Study site

    Vogelsang-Gommern

  • Study site

    Würzburg

Other trials in Germany

Australia3 sites

  • Study site

    Adelaide

  • Study site

    Cotton Tree

  • Study site

    Melbourne

Other trials in Australia

Austria3 sites

  • Study site

    Graz

  • Study site

    Lainz/Wien N/A

  • Study site

    Vienna

Other trials in Austria

Finland3 sites

  • Study site

    Helsinki

  • Study site

    Hyvinkää

  • Study site

    Jyvalskyla

Other trials in Finland

New Zealand3 sites

  • Study site

    Auckland

  • Study site

    Rotorua

  • Study site

    Timaru

Other trials in New Zealand

Spain3 sites

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

United Kingdom3 sites

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Oxford

Other trials in United Kingdom

Netherlands1 site

  • Study site

    Maastricht

Other trials in Netherlands

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).

Read the detailed description

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor-alpha (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 in subjects with active RA previously treated with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab). Concomitant therapy with methotrexate, sulfasalazine and/or hydroxychloroquine is permitted if the subject has tolerated these medications for at least 12 weeks prior to the first administration of study drug and is on a stable dose for at least 4 weeks prior to the first administration of study agent. The study hypothesis is that golimumab will be a safe and effective treatment for RA in subjects with active RA previously treated with at least one biologic anti-TNFa agent as measured by the American College of Rheumatology (ACR) response criteria, the Disease Activity Score 28 (DAS28) responses and the change from baseline in Health Assessment Questionnaire (HAQ), without causing unacceptable significant adverse effects. The ACR response criteria were designed to assess the level of improvement in the signs and symptoms of RA. The DAS28 responses also measure improvement in the signs and symptoms of RA using the joint examination and laboratory testing. The HAQ is a series of questions that measure a subject's impairment in physical function caused by RA. Patients will receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks until Week 24. After Week 24, all subjects receive golimumab 50 mg or 100 mg injections, and golimumab continues for all groups every 4 weeks for about 4 and a half more years.

Being tested
Placebo, Golimumab 50 mg, Golimumab 100 mg
Keywords
Rheumatoid Arthritis, Anti-TNFa agents, 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.

  • PlaceboDrug

    SC injections

  • Golimumab 50 mgBiological

    SC injections

  • Golimumab 100 mgBiological

    SC injections

Study groups in NCT00299546
Study groupRoleWhat they receive
Group 1: PlaceboPlacebo comparatorPlacebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); 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-24 database lock.
Receives: Drug: Placebo; Biological: Golimumab 50 mg
Group 2: Golimumab 50 mgExperimentalGolimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 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-24 database lock.
Receives: Biological: Golimumab 50 mg
Group 3: Golimumab 100 mgExperimentalGolimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period will be until the week-24 database lock.
Receives: Biological: Golimumab 100 mg

What is being measured

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

  1. American College of Rheumatology (ACR) 20 Response at Week 14.

    ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)

    Measured: Week 14

Secondary outcomes (4)

  1. American College of Rheumatology (ACR) 50 Response at Week 14

    Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

    Measured: Week 14

  2. Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14

    DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).

    Measured: Week 14

  3. American College of Rheumatology (ACR) 20 at Week 24

    Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)

    Measured: From Baseline to Week 24

  4. Health Assessment Questionnaire (HAQ) Score at Week 24

    Improvement from baseline in HAQ score at Week 24. This 20-question instrument 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, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.

    Measured: From Baseline to 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 posted7 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2007
  4. Study completionMay 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
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00299546
Sponsor's protocol ID
CR006334
Other IDs
C0524T11
Status last verified
Jan 2014
First submitted
3 Mar 2006
Last updated
27 Feb 2014
Data monitoring committee
Yes

Publications

  • Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

    PubMed 27889300

  • 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

  • Smolen JS, Kay J, Doyle M, Landewe R, Matteson EL, Gaylis N, Wollenhaupt J, Murphy FT, Xu S, Zhou Y, Hsia EC. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor alpha inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther. 2015 Jan 22;17(1):14. doi: 10.1186/s13075-015-0516-6.

    PubMed 25627338

  • Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, Gaylis N, Murphy FT, Neal JS, Zhou Y, Visvanathan S, Hsia EC, Rahman MU; GO-AFTER study investigators. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21. doi: 10.1016/S0140-6736(09)60506-7. Epub 2009 Jun 26.

    PubMed 19560810

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab 50 mg and Golimumab 100 mg in people with Arthritis, Rheumatoid, run by Centocor, Inc. at 77 sites in 10 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 7 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 27 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 77 sites in United States, Canada, Germany, Australia, Austria and 5 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 28 Sep 2011). 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?

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 NCT00299546, which also lists 4 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 27 Feb 2014.

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