A study of long-term effects of fenebrutinib treatment in patients with rheumatoid arthritis

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)

Autoimmune Disorder
Rheumatoid Arthritis

For Patient
For Medical Professional
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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 76 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT02983227, GA30067, 2016-000498-19

Researchers wanted to find out what effect, good or bad, fenebrutinib caused in patients with rheumatoid arthritis (RA) who received long-term treatment. This was an “open-label extension” study. Open-label meant that patients and researchers knew what treatment the patients were getting. It was an “extension study” because RA patients were required to have previously participated in another study that investigated fenebrutinib (and placebo) for RA disease.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT02983227, GA30067, 2016-000498-19

Condition Rheumatoid Arthritis

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

Study 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

Gender

All

Age

≥ 18 Years & ≤ 76 Years

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study of long-term effects of fenebrutinib treatment in patients with rheumatoid arthritis

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS GA30067 Final Results May 2020 English (PDF, 0.1 MB)

LPS GA30067 Final Results May 2020 Brazil Portuguese (PDF, 0.1 MB)

LPS GA30067 Final Results May 2020 Bulgarian (PDF, 0.2 MB)

LPS GA30067 Final Results May 2020 Latin America Spanish (PDF, 0.1 MB)

LPS GA30067 Final Results May 2020 Polish (PDF, 0.2 MB)

LPS GA30067 Final Results May 2020 Russian (PDF, 0.2 MB)

LPS GA30067 Final Results May 2020 Serbian (PDF, 0.2 MB)

LPS GA30067 Final Results May 2020 Ukrainian (PDF, 0.2 MB)

LPS GA30067 Final Results May 2020 US Spanish (PDF, 0.1 MB)

What is Clinical Research?

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A study of long-term effects of fenebrutinib treatment in patients with rheumatoid arthritis

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com