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

Genentech

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: GDC-0853

Study type: Interventional

Funder types: Industry

Identifiers

NCT02983227

GA30067

2016-000498-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 496 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No 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

Trial design

496 participants in 2 patient groups

GDC-0853 (200mg BID) Cohort 1

Experimental group

Description:

Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.

Treatment:

Drug: GDC-0853

GDC-0853 (200mg BID) Cohort 2

Experimental group

Description:

Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.

Treatment:

Drug: GDC-0853