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
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 to 76 - Completion of treatment period through Day 84 as specified in Study GA29350 - Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor - Have not received any prohibited medications in Study GA29350 - While taking MTX, must be willing to receive oral folic acid (at least 5 milligram [mg]/week) 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 430 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Met protocol defined treatment stopping criteria during Study GA29350 - Treatment with any investigational agent (other than study drug) or live/attenuated vaccine during Study GA29350 or since the last administration of study drug in Study GA29350 - In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity, such as neurological, cardiac (e.g., moderate to severe heart failure New York Heart Association [NYHA] Class III/IV), pulmonary, renal, hepatic, endocrine, or GI disorders (excluding RA) that would increase the risk to the patient in Study GA30067 - Pregnant or lactating, or intending to become pregnant during the study - Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator - Patients who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV during the Phase II Study GA29350
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 52 weeks • To evaluate the efficacy of GDC-0853 (analysed separately for methotrexate-inadequate response [MTX-IR] and tumour necrosis factor-inadequate response [TNF-IR] patients) at Week 52 relative to baseline in Study GA29350 ;Secondary Objective: • To determine the improvement in disease activity through 52 weeks of treatment (analysed separately for MTX-IR and TNF-IR patients) relative to baseline in Study GA29350 • To assess Disease Activity Score (DAS28) remission (< 2.6) and Low-disease activity [LDA] (< 3.2) state • To assess American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission according to the Boolean-based definition • To assess simplified disease activity index (SDAI)-based remission (ACR/EULAR remission) and clinical disease activity index (CDAI)-based remission • To assess efficacy based on the individual components of theACR relative to baseline in Study GA29350 • To evaluate the effect of GDC-0853 on health-related quality of life and on fatigue • To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach ;Primary end point(s): Safety: 1. Incidence of adverse events 2. Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC-0853 administration Efficacy: 3. ACR50 response at Week 52 ;Timepoint(s) of evaluation of this end point: Safety: 1-2. Up to 60 weeks Efficacy: 3. Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1. ACR50 response up to Week 12 2. ACR20 and ACR70 3. Disease Activity Score (DAS) 28-3 C-reactive protein (CRP) and DAS 28-4 (CRP) responder rates 4. DAS 28-3 (Erythrocyte Sedimentation Rate [ESR]) and DAS 28-4 (ESR) responder rates 5. DAS28 remission (< 2.6) and LDA (< 3.2) state 6. Boolean based remission 7. Simplified disease activity index-based remission 8. Clinical disease activity index-based remission status 9. Response rates for tender/painful joint count (68) and swollen joint count (66) 10. Patient’s Assessment of Arthritis Pain 11. Patient’s Global Assessment of Arthritis 12. Physician’s Global Assessment of Arthritis 13. CRP 14. Health assessment questionnaire–Disability Index 15. Short-Form 36 Health Survey, standard, Version 2, questionnaire 16. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale PK: 17. Area under the concentration time-curve from time 0 to time t (AUC0-t) 18. Minimum observed plasma concentration (Ctrough) 19. Half-life, apparent (t1/2) 20. Clearance following oral dosing (CL/F) ;Timepoint(s) of evaluation of this end point: Efficacy: 1. Up to Week 12 2-16. Up to Week 52 PK: 17-20. Day (D) 1, D84, D365 and early termination or an unscheduled visit | — |
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