Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis

NCT02983227•Genentech, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 76 years

Sex

ALL

Healthy Volunteers

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

Locations (104)

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Medvin Clinical Research

Covina, California, United States

TriWest Research Associates, LLC

El Cajon, California, United States

Saint Jude Heritage Medical Grp

Fullerton, California, United States

RASF-Clinical Research Center

Boca Raton, Florida, United States

Clinical Research of West Florida

Clearwater, Florida, United States

Medication Management

Greensboro, North Carolina, United States

Oregon Health & Science Uni

Portland, Oregon, United States

Metroplex Clinical Research Centre

Dallas, Texas, United States

Baylor Research Inst.

Dallas, Texas, United States

Key Dates

Start Date

November 30, 2016

Primary Completion Date

July 17, 2019

Completion Date

July 17, 2019

Last Updated

August 3, 2020

Enrollment

496

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

GDC-0853

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis