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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older at the time of signing the informed consent.
Body weight ≥ 30 kilograms at the time of Screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Study Summary
This trial will test if ravulizumab is an effective treatment for dermatomyositis, a disease that causes muscle weakness and skin rashes.
Who is the study for?
Adults with dermatomyositis who've had a poor response or can't tolerate at least one standard treatment, weigh over 30 kg, and are vaccinated against Neisseria meningitidis. Excludes those with recent cancer, certain infections, fever before the trial starts, HIV infection, severe muscle damage as per investigator's judgment.Check my eligibility
What is being tested?
The study is testing Ravulizumab versus a placebo in adults with dermatomyositis to assess its effectiveness and safety. Participants will be randomly assigned to receive either the drug or a placebo without knowing which they're getting (double-blind).See study design
What are the potential side effects?
Potential side effects of Ravulizumab may include reactions related to infusion of the drug into the body, increased risk of infections due to immune system suppression, and possible allergic responses if sensitive to murine proteins or other components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My weight is at least 30 kilograms.
Select...
I am 18 years old or older.
Select...
I weigh at least 30 kilograms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand
Part B: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand
Secondary outcome measures
Part A and B: TIS At Week 26
Part A and Part B: CDASI Response (7-point improvement) at Week 26
Part A and Part B: Change From Baseline In Cutaneous Dermatomyositis Disease Area And Severity Index (CDASI) Activity Score At Week 26
+8 moreSide effects data
From 2022 Phase 3 trial • 195 Patients • NCT0305604031%
Headache
30%
Nasopharyngitis
28%
Upper respiratory tract infection
21%
Fatigue
19%
Diarrhoea
19%
Pyrexia
18%
Nausea
17%
Cough
15%
Abdominal pain
14%
Back pain
14%
Dizziness
13%
Pain in extremity
11%
Arthralgia
11%
Influenza like illness
10%
Oropharyngeal pain
10%
Rhinitis
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Basal cell carcinoma
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment1 Intervention
Participants will receive ravulizumab in both Parts A and B.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo in both Parts A and B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~1080
Find a Location
Who is running the clinical trial?
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,273 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,127 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh at least 30 kilograms.I have tried 2 or more treatments for my condition without success or could not tolerate them.I am HIV positive.I have not had a serious infection in the last 14 days.You have had an allergic reaction to murine proteins or any of the ingredients in ravulizumab.You have been diagnosed with dermatomyositis (DM) based on specific guidelines from medical organizations.I have been vaccinated against Neisseria meningitidis as required, at least 2 weeks before starting the study treatment.I have had a fever of 100.4°F or higher in the last week.I am 18 years old or older.I was diagnosed with myositis close to my cancer diagnosis, excluding certain skin cancers or cervical carcinoma in situ.My weight is at least 30 kilograms.I am either male or female.I am either male or female.I am 18 years old or older.You have a definite or probable diagnosis of DM.I have a type of myositis.I have been diagnosed with cancer within the last 3 years.I am willing to follow the study's rules on birth control.I am following the study's birth control requirements.I have tried at least one DM treatment without success or could not tolerate it.
Research Study Groups:
This trial has the following groups:- Group 1: Ravulizumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other data exists for Ravulizumab?
"Ravulizumab was first studied in 2016 at a clinical trial site. Since then, there have been 18245 completed trials. There are presently 16 actively recruiting trials, with many of these studies being performed in New york, New York."
Answered by AI
Could you please list the various places where this research is conducted?
"There are 8 sites for this clinical trial, which are recruiting patients. The sites are located in New york, Orange and Baltimore, as well as 8 other locations. If you are considering participating, it would be helpful to choose the location nearest to you to reduce travel requirements."
Answered by AI
What are some conditions that ravulizumab is used to treat?
"While Ravulizumab is most commonly used to treat disease activity, it can also help patients suffering from hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome."
Answered by AI
How many study participants are being sought for this research?
"That is correct. The clinical trial is currently recruiting participants, as indicated on clinicaltrials.gov. The listing was first posted on December 2nd, 2021 and was last updated on September 27th, 2022. The trial needs to enroll 150 patients at 8 different sites."
Answered by AI
Are people still being recruited for this trial or has it been completed?
"Yes, this study is still looking for participants. According to the information on clinicaltrials.gov, the trial was first posted on December 2nd, 2021 and was last updated on September 27th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
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