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NCT02291029 · ClinicalTrials.gov registry record · Phase 2
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT02291029: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02291029 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02291029, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
Primary Outcome
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indic
Interventions
- DRUG CFZ533 active - Cohort 1
- DRUG CFZ533 placebo- Cohort 1
- DRUG CFZ533 active - Cohort 2
- DRUG CFZ533 placebo - Cohort 2
- DRUG CFZ533 active -Cohort 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-10-22 |
| Est. Completion | 2018-06-29 |
| Phase | Phase 2 |
What the finished NCT02291029 record still lists
NCT02291029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which CFZ533 active - Cohort 1 is the first listed.
NCT02291029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02291029 about?
NCT02291029 is a clinical study titled "Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome". This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
What is the current status of trial NCT02291029?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2014-10-22. Estimated completion is 2018-06-29.
What interventions are being tested in trial NCT02291029?
The interventions under investigation include: CFZ533 active - Cohort 1 (DRUG), CFZ533 placebo- Cohort 1 (DRUG), CFZ533 active - Cohort 2 (DRUG), CFZ533 placebo - Cohort 2 (DRUG), CFZ533 active -Cohort 3 (DRUG).
Who is sponsoring clinical trial NCT02291029?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02291029's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 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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