Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In very good RA disease control for = 6 months in the opinion of the investigator Receiving treatment with etanercept for RA for = 6 months prior to run-in visit 1 Receiving treatment with methotrexate of 10 mg to 25 mg weekly for = 6 months AND on a stable dose of oral methotrexate for = 8 weeks prior to run-in visit 1 = 18 years of age at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
Exclusion criteria: Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including Human Immunodeficiency Virus infection. Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1. Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to run-in visit 1. Subject has known alcohol addiction or dependency or uses alcohol daily. Subject has used biologic DMARD other than etanercept OR has used an oral janus kinase inhibitor = 6 months prior to run-in visit 1 Subject has known alcohol addiction or dependency or uses alcohol daily. Subject has one or more significant concurrent medical conditions per investigator judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in subjects with rheumatoid arthritis who were on etanercept plus methotrexate combination therapy.;Secondary Objective: To evaluate the efficacy of etanercept plus methotrexate therapy compared to methotrexate monotherapy on maintenance of remission. To evaluate the efficacy of 1) etanercept monotherapy compared to methotrexate monotherapy and 2) etanercept plus methotrexate therapy compared to methotrexate monotherapy on: - disease activity - disease worsening and time to disease worsening - remission and time to recapture remission after rescue treatment ;Primary end point(s): Simplified Disease Activity Index (SDAI) remission (= 3.3);Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. SDAI score and change from baseline at all measured timepoints 2. Disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS-28-ESR) and change from baseline at all measured timepoints 3. Disease activity score (28 joint) using the C-reactive protein formula (DAS-28-CRP) and change from baseline at all measured timepoints 4. Clinical Disease Activity Index (CDAI) and change from baseline at all measured timepoints 5. SDAI remission (= 3.3) at all measured timepoints 6. Boolean remission at all measured timepoints 7. Disease worsening defined as an SDAI > 3.3 and = 11 during two consecutive visits at least 2 weeks apart or SDAI > 3.3 and = 11 on three or more separate visits or SDAI > 11 after randomization 8. Time to disease worsening defined as an SDAI > 3.3 and = 11 during two consecutive visits at least 2 weeks apart or SDAI > 3.3 and = 11 on three or more separate visits or SDAI > 11 after randomization 9. In subjects that receive rescue treatment: • Time to recapture SDAI remission after starting rescue treatment • SDAI remission at week 48;Timepoint(s) of evaluation of this end point: All subjects: •SDAI score, Disease activity score [DAS-28-ESR and DAS-28-CRP], Clinical Disease Activity Index, SDAI remission and Boolean remission evaluated Day 1, week 12, 24, 36 and 48 weeks. •Disease worsening defined as an SDAI > 3.3 and = 11 during two consecutive visits at least 2 weeks apart or SDAI > 3.3 and = 11 on three or more separate visits or SDAI > 11 after randomization. •Time to disease worsening defined as an SDAI > 3.3 and = 11 during two consecutive visits at least 2 weeks apart or SDAI > 3.3 and = 11 on three or more separate visits or SDAI > 11 after randomization. In subjects that receive rescue treatment during the double-blind treatment period: •Time to recapture SDAI remission after starting rescue treatment •SDAI remission at week 48 | — |
Countries
Argentina, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed