Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: GDC-0853
Product Code: RO7010939
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Current Sponsor code: GDC-
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 to 75 years at screening - Diagnosis of adult-onset RA as defined by the 2010 ACR/European League Against Rheumatism (EULAR) Classification Criteria for RA - Currently active RA disease activity as determined by joint counts and laboratory markers of inflammation - For MTX-IR patients: must have had an inadequate response to methotrexate - For TNF-IR patients: must have had an inadequate response to 1 or 2 TNF inhibitors 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 445 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 155
Exclusion criteria
Exclusion criteria: - History of or current inflammatory joint disease other than RA or other systemic autoimmune disorders -Any condition or medication that precludes the use of or is contraindicated with MTX or folic acid, according to local prescribing label of the investigator - For MTX-IR patients: History of treatment with any TNF inhibitor, including biosimilar equivalents - For all patients: Previous treatment with any non-TNF inhibitor biologic DMARDs (including biosimilar equivalents), tofacitinib, other Janus kinase inhibitor(s), or alkylating agents - Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or GI disease - Evidence of chronic and/or active hepatitis B or C - Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy and safety of GDC-0853 compared with placebo used in combination with stable doses of methotrexate (MTX) in patients (Pts) with active RA who have had an inadequate response (IR) to MTX and are naive to tumour necrosis factor (TNF) therapy; Secondary Objective: •To evaluate the efficacy of GDC-0853 -Compared with adalimumab used in combination with stable doses of MTX in Pts with active RA who have had IR to MTX and who are naive to TNF therapy -Compared with placebo used in combination with stable doses of MTX in Pts with active RA who have had IR or intolerance to 1 or 2 TNF inhibitors -Over time with multiple standardized assessments •To assess efficacy based on the individual components of the American College of Rheumatology (ACR) response criteria for RA •To assess Disease Activity Score 28 remission (< 2.6), Low-disease activity (< 3.2) state, and remission based on Clinical Disease Activitiy Index ; ACR/ EULAR Boolean and Simplified Disease Activity Index •To evaluate the effect of GDC-0853 compared with placebo on healthrelated quality of life and on fatigue •To evaluate the safety and pharmacokinetics of GDC-0853 in combination with MTX in Pts with active RA E. ;Primary end point(s): 1. ACR50 response rates;Timepoint(s) of evaluation of this end point: 1. Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1. ACR20 and ACR70 responder rates 2. Disease Activity Score (DAS) 28-3 (CRP) and DAS 28-4 (CRP) responder rates 3. DAS 28-3 (Erythrocyte Sedimentation Rate [ESR]) and DAS 28-4 (ESR) responder rates 4. Response rates for tender/painful joint count (68) and swollen joint count (66) 5. Patient’s assessment of arthritis pain 6. Patient’s global assessment of arthritis 7. Physician’s global assessment of arthritis 8. CRP 9. Health assessment questionnaire – Disability Index 10. DAS28 remission (< 2.6) and Low-disease activity (< 3.2) state 11. ACR/EULAR Boolean based remission 12. Change from baseline ACR/EULAR simplified disease activity index-based remission 13. Change from baseline Clinical disease activity index-based remission 14. Short-Form 36 Health Survey 15. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue measure Safety: 16. Incidence of adverse events, changes in vital signs, physical findings, ECGs, and clinical laboratory results following GDC-0853 administration PK: 17. Area under the concentration time-curve of GDC-0853 18. Maximum observed plasma concentration of GDC-0853 19. Time to maximum concentration of GDC-0853 20. Minimum observed plasma concentration of GDC-0853 21. Half-life of GDC-0853 22. Apparent clearance of GDC-0853 ; Timepoint(s) of evaluation of this end point: Efficacy: 1-13. Days 7, 14, 28, 56, and 84 14-15. Day 84 Safety: 16. Up to 24 weeks PK: 17-22 | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Korea, Republic of, Mexico, Poland, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed