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
Completed · Phase 2
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT02983227
- Run by
- Genentech, Inc.
- People needed
- 496
- Starts
- 2016-11-30
- Expected to finish
- 2019-07-17
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Accurate Clinical Research — Houston, Texas, United States
- Instituto de Investigaciones Clinicas-Mar del Plata — Buenos Aires, Argentina
- APRILLUS — Buenos Aires, Argentina
- Instituto centenario — Buenos Aires, Argentina
- Centro de Investigacion en Enfermedades Reumaticas CIER — Ciudad Autonoma Buenos Aires, Argentina
- Expertia S.A- Mautalen Salud e Investigación — Ciudad Autonoma Buenos Aires, Argentina
- CCBR - Buenos Aires - AR; AxisMed SRL — Ciudad Autonoma Buenos Aires, Argentina
- ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas — Córdoba, Argentina
- Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina
- Instituto de Investigaciones Clinicas — Rosario, Argentina
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina
- Centro Medico Privado de Reumatologia; Reumathology — San Miguel, Argentina
- CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica — Goiânia, Goiás, Brazil
- CMiP - Centro Mineiro de Pesquisa*X* — Juiz de Fora, Minas Gerais, Brazil
- Centro de Estudos em Terapias Inovadoras - CETI — Curtiba, Paraná, Brazil
- Arizona Arthritis & Rheumatology Associates, P.C. — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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