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A Study In Adults With Moderate To Severe Dermatomyositis

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dermatomyositis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have CDASI Activity score of greater than or equal to 14, and have failed at
least 1 standard of care systemic treatment, (eg, corticosteroids).

- Confirmation of DM by the investigator and two of the following:

1. Gottron's papules;

2. Gottron's sign;

3. Heliotrope eruption;

4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular
hypertrophy and/or rugged cuticles;

5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and
appears purplish/reddish, and patchy in appearance;

6. Positive DM serology -

- Post DM diagnosis; standard of care workup for DM must have been completed prior to
entry into this research study.

- Willing to provide 6 biopsies during the course of the research study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Investigator site staff or members of their family.

- Acute and Chronic present medical conditions

- Intake of greater than 15 mg of prednisone or equivalent per day

- Pregnant or breastfeeding females. Fertile men and women who will not comply with the
use of 2 effective birth control methods as per the research protocol

- Have required management of acute or chronic infections

- Have pre existing demyelinating disorder such as multiple sclerosis, or other severe
neurological deficits.

- Clinically significant lab abnormalities

- Any health condition that may be worsened by immunosuppression

NCT03181893
Pfizer
Recruiting
A Study In Adults With Moderate To Severe Dermatomyositis

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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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October 27, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids).
  • Confirmation of DM by the investigator and two of the following:

    1. Gottron's papules;
    2. Gottron's sign;
    3. Heliotrope eruption;
    4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
    5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
    6. Positive DM serology -
  • Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study.
  • Willing to provide 6 biopsies during the course of the research study

Exclusion Criteria:

  • Investigator site staff or members of their family.
  • Acute and Chronic present medical conditions
  • Intake of greater than 15 mg of prednisone or equivalent per day
  • Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol
  • Have required management of acute or chronic infections
  • Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits.
  • Clinically significant lab abnormalities
  • Any health condition that may be worsened by immunosuppression
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03181893
C0251002
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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