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NCT02833350 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 578
- Enrollment target
NCT02833350: Completed Phase 2 study, sponsored by Genentech.
NCT02833350 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 578 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (335% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02833350, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 578 participants
- Enrollment target
Study Summary
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).
Primary Outcome
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease
Interventions
- DRUG Placebo
- DRUG Adalimumab
- DRUG Folic Acid
- DRUG MTX
- DRUG GDC-0853
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2016-09-09 |
| Est. Completion | 2018-07-02 |
| Phase | Phase 2 |
What the finished NCT02833350 record still lists
NCT02833350 is an interventional study that assigns participants to a tested intervention. The registered 578 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (335% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02833350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02833350 about?
NCT02833350 is a clinical study titled "Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)". This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (...
What is the current status of trial NCT02833350?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 578 participants. The study started on 2016-09-09. Estimated completion is 2018-07-02.
What interventions are being tested in trial NCT02833350?
The interventions under investigation include: Placebo (DRUG), Adalimumab (DRUG), Folic Acid (DRUG), MTX (DRUG), GDC-0853 (DRUG).
Who is sponsoring clinical trial NCT02833350?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02833350's enrollment target sits among peer trials
578 59th of 2000 higher than 1,942 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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