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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new medication called PF-06823859 to see if it is safe and can be tolerated in adults with Dermatomyositis, a condition that causes muscle and skin inflammation.
Eligible Conditions
- Dermatomyositis
- Systemic Lupus Erythematosus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change Over Time In the Health Assessment Quality of Life and Disability Index (HAQ-DI)
Change Over Time In the Myositis Disease Activity Assessment Tool
Change Over Time In the Physician Global Assessment (PhGA)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Anti-Beta Interferon drug (PF-06823859)Experimental Treatment1 Intervention
IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-Beta Interferon (PF-06823859)
2021
Completed Phase 2
~30
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Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,401 Total Patients Enrolled
3 Trials studying Dermatomyositis
355 Patients Enrolled for Dermatomyositis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,577 Total Patients Enrolled
2 Trials studying Dermatomyositis
345 Patients Enrolled for Dermatomyositis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical or mental condition, or recent thoughts of harming yourself, that may make it risky for you to participate in the study.You stopped participating in the previous qualifying studies for any reason.You are currently experiencing a safety issue from a previous study that hasn't been resolved yet.You are between 18 and 80 years old and have moderate to severe dermatomyositis.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-Beta Interferon drug (PF-06823859)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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