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 (NCT02833350)



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 76
Updated:1/11/2019
Start Date:November 30, 2016
End Date:July 27, 2019

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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

This is a Phase II, multicenter, open-label extension study to evaluate the long-term safety
and efficacy of GDC-0853 in participants with moderate to severe active RA who have completed
12 weeks of study treatment in Study GA29350 (NCT02833350). 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.


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 [ [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
We found this trial at
14
sites
2147 Northeast Coachman Road
Clearwater, Florida 33765
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Boca Raton, Florida
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Boca Raton, FL
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Buenos Aires,
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Covina, California 91723
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Covina, CA
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3310 Live Oak Street
Dallas, Texas 75246
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Dallas, TX
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8144 Walnut Hill Lane
Dallas, Texas 75325
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Dallas, TX
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Danville, Virginia 24541
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Danville, VA
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El Cajon, California 92020
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El Cajon, CA
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2141 North Harbor Boulevard
Fullerton, California 92835
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Fullerton, CA
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Glendale, AZ
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Greensboro, North Carolina 27408
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Greensboro, NC
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Houston, TX
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1951 Northwest 7th Avenue
Miami, Florida 33136
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Miami, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Portland, OR
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