Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: SC golimumab; IV golimumab
Intervention description: Subcutaneous golimumab at a dose of 50 mg administered once monthly.; 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 MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3366.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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