Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00361335

Rheumatoid Arthritis

COMPLETED PHASE3

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

NCT01004432

Arthritis Arthritis, Rheumatoid Autoimmune Diseases

COMPLETED PHASE3

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT00264550

Rheumatoid Arthritis

COMPLETED PHASE3

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

NCT00973479

Arthritis, Rheumatoid

COMPLETED PHASE3

A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

NCT01362153

Rheumatoid Arthritis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis, Rheumatoid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SC-GLM50

In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment.

Group Type EXPERIMENTAL

SC golimumab

Intervention Type BIOLOGICAL

Subcutaneous golimumab at a dose of 50 mg administered once monthly.

IV GLM 2 mg/kg + GLM50-SC

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment.

Group Type EXPERIMENTAL

SC golimumab

Intervention Type BIOLOGICAL

Subcutaneous golimumab at a dose of 50 mg administered once monthly.

IV golimumab

Intervention Type BIOLOGICAL

Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.

GLM50-SC

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment.

Group Type EXPERIMENTAL

SC golimumab

Intervention Type BIOLOGICAL

Subcutaneous golimumab at a dose of 50 mg administered once monthly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SC golimumab

Subcutaneous golimumab at a dose of 50 mg administered once monthly.

Intervention Type BIOLOGICAL

IV golimumab

Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SCH 900259, subcutaneous SCH 900259, intravenous

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

For Part 1:

* Age \>=18 years, either sex, any race.
* Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
* Active disease despite DMARD treatment
* Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
* Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:

* Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
* Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis \[TB\] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
* Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.

For Part 2:

* Participant must have completed Part 1 of this trial.
* Participant must have:

* good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
* no DAS28 ESR remission.
* Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.
* The investigator must judge that no safety events (eg, serious adverse events \[SAEs\], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.

Exclusion Criteria

* History of biologic drug use for RA.
* Evidence of active TB. or latent TB that is untreated.
* Moderate to severe heart failure
* Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
* Allergy to latex

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No