Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
With
Integrated Therapeutics Group
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
aged 18 years or more
with RA according to ACR criteria
presented with a disease flare after initial response to infliximab, with both response and flare being defined using the DAS28 score (EULAR criteria)
received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0, 2, 6, \[and 14\])
an initial response documented by moderate or good DAS28 improvement (EULAR criteria) from Week 0 to Week 6 or 14.
You may not be if
a female who is, or intends to become, pregnant during or within 6 months of the end of the study, is nursing or not using adequate contraceptive measures
has not observed the designated periods for concomitant medications
used any investigational medical product within 30 days prior to Baseline
any clinically significant deviation from normal in the physical examination or chest X-ray that in the investigator's judgment, may interfere with the study evaluation or affect subject safety
rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity
allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.
