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
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GDC-0853
Intervention description: GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 496.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

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 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