Phase 2
Completed N=496
A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350
Source: ClinicalTrials.gov NCT02983227 ↗Enrolled (actual)
496
Serious AEs
6.1%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 60.2; 57.0 Percentage
Summary
A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
60.2; 57.0 | — |
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52 |
57.1; 50.0 | — |
| SECONDARY Percentage of Participants Achieving ACR50 Response up to Week 12 |
37.1; 29.1; 42.4; 34.9; 45.6; 39.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
69.0; 58.1; 72.9; 68.6; 74.4; 73.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
19.8; 12.8; 21.7; 17.4; 23.9; 19.8 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) |
5.49; 5.59; 3.64; 4.09; 3.48; 3.81 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) |
5.83; 5.95; 3.70; 4.22; 3.53; 3.92 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) |
6.17; 6.38; 4.25; 4.80; 4.04; 4.51 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) |
6.48; 6.71; 4.27; 4.89; 4.04; 4.58 | — |
| SECONDARY Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) |
8.8; 7.0; 10.7; 8.1; 13.9; 8.1 | — |
| SECONDARY Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 |
20.0; 12.8; 21.2; 17.4; 26.6; 12.8 | — |
| SECONDARY Percentage of Participants With ACR/EULAR Remission |
5.0; 5.8; 7.8; 5.9; 7.4; 7.2 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) |
-24.36; -21.00; -26.17; -24.06; -27.91; -25.21 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) |
-23.41; -19.81; -25.14; -22.48; -26.82; -23.82 | — |
| SECONDARY Change From Baseline in Tender/Painful Joint Count Based on 68 Joints |
-15.02; -13.23; -16.11; -15.19; -16.55; -15.99 | — |
| SECONDARY Change From Baseline in Swollen Joint Count Based on 66 Joints |
-10.20; -7.85; -10.95; -9.12; -11.40; -9.08 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score |
-30.62; -26.34; -32.57; -27.21; -35.68; -29.49 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score |
-30.21; -26.03; -32.67; -28.79; -35.63; -31.16 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score |
-37.07; -30.65; -39.29; -35.32; -42.23; -37.37 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) Levels |
-0.95; -1.09; -1.02; -1.58; -1.03; -1.40 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.70; -0.55; -0.77; -0.59; -0.80; -0.60 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components |
11.35; 8.22; 6.52; 4.74; 12.31; 8.28 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score |
11.44; 9.28; 11.74; 10.41; 12.87; 10.87 | — |
| SECONDARY Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss) |
13400; 15600 | — |
| SECONDARY Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss) |
387; 467 | — |
| SECONDARY Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss) |
7.94; 9.01 | — |
| SECONDARY Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss) |
39.5; 35.3 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
- 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 methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
- If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350
Exclusion Criteria
- Met protocol defined treatment stopping criteria during Study GA29350
- Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication 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 that would increase the risk to the participant in Study GA30067
- Pregnant or lactating, or intending to become pregnant during the study
- Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
- Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
- Participants who developed a malignancy during the Phase II Study GA29350
- 12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Current treatment with medications that are well known to prolong the QT interval
Data sourced from ClinicalTrials.gov (NCT02983227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.