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)
18 Years
N/A
Both
Arthritis, Rheumatoid
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6
Outcome Description:
EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units
Outcome Time Frame:
Month 6
Safety Issue:
No
Authority:
Canada: Health Canada
Study ID:
P06129
NCT ID:
NCT00975130
Start Date:
September 2009
Completion Date:
February 2012
Related Keywords:
- Arthritis, Rheumatoid
- Arthritis
- Arthritis, Rheumatoid
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