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ArthritisPhase 3NCT01004432

Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

A Phase 3 study testing Golimumab 50 mg SC, Golimumab 2 mg/kg IV and Methotrexate (MTX) in people with Arthritis and Arthritis, Rheumatoid, run by Janssen Biotech, Inc. at 117 sites in 8 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 switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Golimumab 50 mg SC, Golimumab 2 mg/kg IV and Methotrexate (MTX)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
433 participants
Where
117 sitesin 8 countries
Study dates
Dec 2009to Oct 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

  • Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
  • Must have received a stable dose of MTX greater than or equal to (>=) 7.5 milligram (mg) per week to less than or equal to (<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
  • Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
  • Negative tuberculosis (TB) test
  • Are capable of providing informed consent, which must be obtained prior to any study-related procedures

Who cannot join

  • Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection
  • Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease
  • Have demonstrated a discernible improvement in disease activity between screening and prior to the first golimumab injection at Week 0
  • Have any known malignancy or have a 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)
  • Have a history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location

Trial locations and contacts

117 sites in 8 countries.

117 sites in 8 countries

United States89 sites

  • Study site

    Akron, Ohio

  • Study site

    Arlington, Virginia

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Beckley, West Virginia

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Bettendorf, Iowa

  • Study site

    Birmingham, Alabama

  • Study site

    Bowling Green, Kentucky

  • Study site

    Bridgeport, Connecticut

  • Study site

    Brooklyn, New York

  • Study site

    Carrollton, Texas

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesapeake, Virginia

  • Study site

    Clarksburg, West Virginia

  • Study site

    Clayton, Missouri

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Covina, California

  • Study site

    Dallas, Texas

  • Study site

    Duluth, Georgia

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edmond, Oklahoma

  • Study site

    Florissant, Missouri

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Freehold, New Jersey

  • Study site

    Glendale, Wisconsin

  • Study site

    Greenville, North Carolina

  • Study site

    Hamden, Connecticut

  • Study site

    Hemet, California

  • Study site

    Hickory, North Carolina

  • Study site

    Hixson, Tennessee

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Kingsport, Tennessee

  • Study site

    Knoxville, Tennessee

  • Study site

    Lake Oswego, Oregon

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Loma Linda, California

  • Study site

    Long Beach, California

  • Study site

    Mayfield, Ohio

  • Study site

    Mesa, Arizona

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Mineola, New York

  • Study site

    Monroe, Louisiana

  • Study site

    Murrieta, California

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange Park, Florida

  • Study site

    Orlando, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Plainview, New York

  • Study site

    Plantation, Florida

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    San Antonio, Texas

  • Study site

    Santa Maria, California

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Seattle, Washington

  • Study site

    Smithtown, New York

  • Study site

    South Bend, Indiana

  • Study site

    Spokane, Washington

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Trumbull, Connecticut

  • Study site

    Tupelo, Mississippi

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Van Nuys, California

  • Study site

    Victorville, California

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wexford, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Whittier, California

  • Study site

    Wilmington, North Carolina

Other trials in United States

Canada8 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    St. Johns

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

United Kingdom7 sites

  • Study site

    Cannock

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Merseyside

  • Study site

    Newcastle upon Tyne

  • Study site

    Wigan

Other trials in United Kingdom

Belgium5 sites

  • Study site

    Brussels

  • Study site

    Genk

  • Study site

    Ghent

  • Study site

    Liège

  • Study site

    Merksem

Other trials in Belgium

Germany4 sites

  • Study site

    Hamburg

  • Study site

    Herne

  • Study site

    München

  • Study site

    Ratingen

Other trials in Germany

Greece2 sites

  • Study site

    Heraklion- Crete

  • Study site

    Thessalonikis

Other trials in Greece

Austria1 site

  • Study site

    Vienna

Other trials in Austria

Sweden1 site

  • Study site

    Stockholm

Other trials in Sweden

About this study

Official title: A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Read the detailed description

The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.

Being tested
Golimumab 50 mg SC, Golimumab 2 mg/kg IV, Methotrexate (MTX), Placebo SC, Placebo IV
Keywords
humira, remicade, rheumatoid arthritis, enbrel failure, humira failure, arthritis, enbrel
Medical subject headings
Arthritis, Arthritis, Rheumatoid, Autoimmune Diseases

What participants receive

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

  • Golimumab 50 mg SCDrug

    Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

  • Golimumab 2 mg/kg IVDrug

    Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.

  • Methotrexate (MTX)Drug

    Participants will continue taking their current Methotrexate (MTX) treatment regimen.

  • Placebo SCDrug

    Placebo matched to golimumab SC injection every 4 weeks.

  • Placebo IVDrug

    Placebo matched to golimumab intravenous infusion every 8 weeks.

Study groups in NCT01004432
Study groupRoleWhat they receive
Open-label (OL) Overall Group: Golimumab 50 mg SC + MTXExperimentalAll enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12.
Receives: Drug: Golimumab 50 mg SC; Drug: Methotrexate (MTX)
Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTXExperimentalParticipants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
Receives: Drug: Golimumab 50 mg SC; Drug: Methotrexate (MTX); Drug: Placebo IV
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTXExperimentalParticipants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
Receives: Drug: Golimumab 2 mg/kg IV; Drug: Methotrexate (MTX); Drug: Placebo SC
OL Group 1: Golimumab 50 mg SC + MTXExperimentalParticipants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48.
Receives: Drug: Golimumab 50 mg SC; Drug: Methotrexate (MTX)
OL Study Extension Group: Golimumab 50 mg SC + MTXExperimentalParticipants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Receives: Drug: Golimumab 50 mg SC; Drug: Methotrexate (MTX)

What is being measured

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

  1. Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14

    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.

    Measured: Week 14

Secondary outcomes (5)

  1. Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2

    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.

    Measured: Within 2 weeks of initiating therapy

  2. Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52

    Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.

    Measured: Week 52

  3. Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16

    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.

    Measured: Week 52

  4. Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16

    Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.

    Measured: Week 76

  5. Change in ESR-based DAS28 Score at Week 76 Relative to Week 52

    Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.

    Measured: Week 52, 76

Timeline

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

  1. First posted30 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2013
  4. Study completionOct 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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
433 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004432
Sponsor's protocol ID
CR016663
Other IDs
CNTO148ART3002, 2009-010582-23, GO SAVE, 2009
Status last verified
Apr 2015
First submitted
29 Oct 2009
Last updated
30 Apr 2015
Data monitoring committee
Yes

Publications

  • Dehoratius RJ, Brent LH, Curtis JR, Ellis LA, Tang KL. Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. Patient. 2018 Jun;11(3):361-369. doi: 10.1007/s40271-018-0297-5.

    PubMed 29427176

  • Huffstutter JE, Kafka S, Brent LH, Matucci-Cerinic M, Tang KL, Chevrier M, Sprabery T, DeHoratius RJ. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017 Apr;33(4):657-666. doi: 10.1080/03007995.2016.1277195. Epub 2017 Jan 25.

    PubMed 28035867

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab 50 mg SC, Golimumab 2 mg/kg IV and Methotrexate (MTX) in people with Arthritis and Arthritis, Rheumatoid, run by Janssen Biotech, Inc. at 117 sites in 8 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Canada, United Kingdom, Belgium, Germany and 3 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 May 2014). 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?

Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based 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 NCT01004432, which also lists 2 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 30 Apr 2015.

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