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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)

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ClinicalTrials.gov Identifier: NCT02983227
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
RheumatoId Arthritis Drug: GDC 0853 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 497 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GDC-0853
Participants after completing 12 weeks of treatment with GDC-0853 in Study GA29350, will receive GDC-0853 orally BID for 52 weeks.
Drug: GDC 0853
GDC-0853 tablet will be administered orally BID for 52 weeks.
Other Name: RO7010939




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events [ Time Frame: Day 1 up to 8 weeks after last dose (up to Week 60) ]
  2. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52 [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving ACR50 Response up to Week 12 [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
  2. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  3. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  4. Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  5. Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  6. Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  7. Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  8. Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  9. Percentage of Participants With Low Disease Activity Based on DAS28 [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  10. Percentage of Participants With Remission Assessed Using Boolean Criteria, defined as Tender Joint Count (TJC) of 1 or less, Swollen Joint Count (SJC) of 1 or less, CRP of 1mg/dL or less, and Patient Global Assessment of 1 or less [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  11. Percentage of Participants With Remission Based on Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  12. Percentage of Participants With Remission Based on Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  13. Tender/Painful Joint Count Based on 68 Joints [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  14. Swollen Joint Count Based on 66 Joints [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  15. Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  16. Patient's Global Assessment of Arthritis, Using VAS Score [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  17. Physician's Global Assessment of Arthritis, Using VAS Score [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  18. C-Reactive Protein (CRP) Levels [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  19. Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 52 ]
  20. 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Score [ Time Frame: Baseline, Weeks 12, 24, and 52 ]
  21. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Score [ Time Frame: Baseline, Weeks 12, 24, and 52 ]
  22. Area Under the Concentration Time Curve (AUC) of GDC-0853 [ Time Frame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination ]
  23. Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss) [ Time Frame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination ]
  24. Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss) [ Time Frame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination ]
  25. Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss) [ Time Frame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983227


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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02983227     History of Changes
Other Study ID Numbers: GA30067
2016-000498-19 ( EudraCT Number )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases