Status:
COMPLETED
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dru...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
3366 Patients enrolled
Trial Details
Trial ID
NCT00975130
Start Date
September 1 2009
End Date
February 1 2012
Last Update
April 13 2017
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