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

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

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.

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.

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