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Rheumatoid ArthritisPhase 3NCT00361335

A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 3 study testing Golimumab and Methotrexate in people with Rheumatoid Arthritis, run by Centocor, Inc. at 72 sites in 15 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 assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. 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?
Golimumab and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
643 participants
Where
72 sitesin 15 countries
Study dates
Sep 2006to Sep 2009
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

  • Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent

Who cannot join

  • Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening

Trial locations and contacts

72 sites in 15 countries.

72 sites in 15 countries

United States20 sites

  • Study site

    Albany, New York

  • Study site

    Amarillo, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aventura, Florida

  • Study site

    Charlotte, North Carolina

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Fort Worth, Texas

  • Study site

    Lincoln, Nebraska

  • Study site

    Lubbock, Texas

  • Study site

    Norristown, Pennsylvania

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Peoria, Arizona

  • Study site

    Roslyn, New York

  • Study site

    Spokane, Washington

  • Study site

    Tampa, Florida

  • Study site

    Voorhees Township, New Jersey

  • Study site

    West Reading, Pennsylvania

  • Study site

    Willow Grove, Pennsylvania

Other trials in United States

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

Australia6 sites

  • Study site

    Fitzroy

  • Study site

    Heidelberg

  • Study site

    Maroochydore

  • Study site

    Melbourne

  • Study site

    Perth

  • Study site

    Woodville

Other trials in Australia

New Zealand5 sites

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Rotorua

  • Study site

    Takapuna Auckland

  • Study site

    Timaru

Other trials in New Zealand

Poland5 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Krakow

  • Study site

    Warsaw

  • Study site

    Włoszczowa

Other trials in Poland

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Floridablanca

Other trials in Colombia

Germany4 sites

  • Study site

    Erlangen

  • Study site

    Hamburg

  • Study site

    Magdeburg

  • Study site

    München

Other trials in Germany

Lithuania4 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

Other trials in Lithuania

Malaysia4 sites

  • Study site

    Ipoh

  • Study site

    Kuching

  • Study site

    Precinct 7

  • Study site

    Selangor Darul Ehasan

Other trials in Malaysia

Mexico4 sites

  • Study site

    Colonia del Valle

  • Study site

    Guadalajara

  • Study site

    Guadalajara Jalisco

  • Study site

    Monterrey

Other trials in Mexico

Ukraine4 sites

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Symferpol

  • Study site

    Zhaporizhzhya

Other trials in Ukraine

Hungary2 sites

  • Study site

    Budapest

  • Study site

    Szolnok

Other trials in Hungary

Latvia2 sites

  • Study site

    Daugavpils

  • Study site

    Riga

Other trials in Latvia

Malta1 site

  • Study site

    Msd06 Gwardiamangia

Other trials in Malta

Peru1 site

  • Study site

    Lima

Other trials in Peru

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.

Read the detailed description

This is a Phase III, double blind (neither investigator nor participant knows the treatment received), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), multicenter, 5-arm (treatment groups) study of golimumab at 2 doses (given with or without MTX over a period of 30 minutes) for at least 48 weeks in patients with active RA despite concurrent MTX therapy. The study consists of a treatment period of golimumab IV infusions (IV Period) which ranges from 48 weeks to approximately 140 weeks, assuming an enrollment period of approximately 92 weeks, and a long-term optional extension period (Extension Study) in which golimumab SC injections will be given for 24 weeks. The end of study will be the time the last participant completes the Week E-40 visit (Extension Study) for safety follow-up assessments. For the IV Period, participants will be randomly assigned to 1 of the 5 treatment groups in a 1:1:1:1:1 ratio (approximately 125 patients per group). At Week 16 and Week 24, joint assessment results will be used to allow participants to enter early escape and dose regimen adjustment, respectively, in a blinded fashion. Treatment will be unblinded after the 48-week database lock and participants will be given the option to participate in the Extension Study and receive SC injections of 50mg golimumab (with or without MTX) every 4 weeks for an additional 24 weeks. Safety will be monitored throughout the study. The entire study duration (IV Period plus Extension Study) for each participant will range from 88 weeks up to 192 weeks, assuming an enrollment period of approximately 92 weeks.

Being tested
Golimumab, Methotrexate, Placebo
Keywords
Rheumatoid arthritis, Golimumab, Methotrexate, Tumor Necrosis Factor-alpha, Immunology
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

    2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes

  • MethotrexateDrug

    Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.

  • PlaceboDrug

    Also called sham MTX

    Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.

Study groups in NCT00361335
Study groupRoleWhat they receive
Group I: 2mg/kg Golimumab + MTXExperimentalIntravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive methotrexate (MTX) at the same dose as that before study entry
Receives: Drug: Golimumab; Drug: Methotrexate
Group II: 2mg/kg Golimumab onlyExperimentalIV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX or switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules
Receives: Drug: Golimumab; Drug: Placebo
Group III: 4mg/kg Golimumab + MTXExperimentalIV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive MTX at the same dose as that before study entry.
Receives: Drug: Golimumab; Drug: Methotrexate
Group IV: 4mg/kg Golimumab onlyExperimentalIV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules.
Receives: Drug: Golimumab; Drug: Placebo
Group V: IV Placebo + MTXPlacebo comparatorIV infusions of placebo at Week 0 and Week 12 with early escape (switch to 4mg/kg IV golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (placebo plus golimumab) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition patients will receive MTX at the same dose as that before study entry. Participants still receiving placebo injections at Week 48 are not eligible to enter the Extension Study.
Receives: Drug: Methotrexate; Drug: Placebo

What is being measured

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

  1. Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14

    An ACR 50 response is defined as a greater than or equal to 50 percentage 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 (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 (CRP).

    Measured: Week 0 to Week 14

Secondary outcomes (4)

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

    ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).

    Measured: Week 0 to Week 24

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

    ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).

    Measured: Week 0 to Week 14

  3. Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14

    DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2

    Measured: Week 0 to Week 14

  4. Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14

    The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.

    Measured: Weeks 0 to Week 14

Timeline

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

  1. First posted8 Aug 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionDec 2007
  4. Study completionSep 2009

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
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00361335
Sponsor's protocol ID
CR012781
Other IDs
C0524T12, 2005-003232-21, 2005
Status last verified
Jul 2014
First submitted
4 Aug 2006
Last updated
29 Jul 2014
Data monitoring committee
Yes

Publications

  • George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12.

    PubMed 28606966

  • Baker JF, Conaghan PG, Smolen JS, Aletaha D, Shults J, Emery P, Baker DG, Ostergaard M. Development and validation of modified disease activity scores in rheumatoid arthritis: superior correlation with magnetic resonance imaging-detected synovitis and radiographic progression. Arthritis Rheumatol. 2014 Apr;66(4):794-802. doi: 10.1002/art.38304.

    PubMed 24757132

  • Baker JF, Baker DG, Toedter G, Shults J, Von Feldt JM, Leonard MB. Associations between vitamin D, disease activity, and clinical response to therapy in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Sep-Oct;30(5):658-64. Epub 2012 Oct 17.

    PubMed 22776409

  • Taylor PC, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Mack M, Kremer J. Maintenance of efficacy and safety with subcutaneous golimumab among patients with active rheumatoid arthritis who previously received intravenous golimumab. J Rheumatol. 2011 Dec;38(12):2572-80. doi: 10.3899/jrheum.110570. Epub 2011 Nov 15.

    PubMed 22089463

  • Kremer J, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Han J, Taylor P. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010 Apr;62(4):917-28. doi: 10.1002/art.27348.

    PubMed 20131276

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab and Methotrexate in people with Rheumatoid Arthritis, run by Centocor, Inc. at 72 sites in 15 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 1 inclusion and 1 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Argentina, Australia, New Zealand, Poland and 10 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 24 Aug 2012). 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 an American College of Rheumatology (ACR) 50 Response at Week 14 (time frame: Week 0 to 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 NCT00361335, 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 29 Jul 2014.

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