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Monoclonal Antibodies
Brentuximab Vedotin for Systemic Sclerosis
Phase 2
Waitlist Available
Led By Janet E Pope
Research Sponsored by Lawson Health Research Institute
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 3,6,9 and 12 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating a form of scleroderma.
Eligible Conditions
- Systemic Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3,6,9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3,6,9 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in skin thickness measured by modified Rodnan Skin Score (mRSS)
Secondary outcome measures
CRISS score >20%
Change in DLCO, %
Change in FVC, %
+5 moreOther outcome measures
Change in CD30-positive cell count in skin biopsies of involved forearm skin
Change in blood levels of soluble CD30
Change in erythrocyte sedimentation rate
+6 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Anaphylactic reaction
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of Brentuximab vedotinExperimental Treatment1 Intervention
Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg/kg Route of administration: intravenous use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Find a Location
Who is running the clinical trial?
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,146 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,417 Total Patients Enrolled
Janet E PopePrincipal InvestigatorUniversity of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a long-lasting or ongoing infectious disease that needs treatment throughout your body.You have taken brentuximab vedotin in the past.You have been diagnosed with a specific type of scleroderma called diffuse cutaneous systemic sclerosis (dcSSc) within the past 5 years, or you currently have active dcSSc based on symptoms like worsening skin tightness, tendon friction rubs, and elevated markers of inflammation.You have a known or suspected allergy to any of the ingredients in the treatment.You have a serious condition called pulmonary hypertension that requires medication treatment.You have a serious heart condition that could affect your participation in the study.You have a serious medical condition that is not under control, such as problems with your kidneys, liver, pancreas, blood, stomach, hormones, lungs, brain, or mental health. You also have cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of Brentuximab vedotin
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participation in this clinical trial?
"Affirmative. According to the clinicaltrials.gov, this trial is still actively recruiting participants since its original posting on May 7th 2019 and last update on February 3rd 2022. The study requires 11 patients from a single site for enrollment."
Answered by AI
What other experimental applications have there been for Brentuximab Vedotin?
"At the moment, 59 studies concerning Brentuximab Vedotin are in progress. Of those trials, 6 have reached Phase 3 status. Although most research related to this therapy is located in Montvale New jersey, 1,851 sites across the country are studying it."
Answered by AI
Is this particular clinical trial a pioneering effort?
"Brentuximab Vedotin has been studied in 630 cities and 31 countries since its first clinical trial in 2011. Seagen Inc. sponsored the initial Phase 2 study, which involved 79 participants. Since then, 53 additional trials have taken place."
Answered by AI
Is there an open enrollment period for this research project currently?
"Per the records on clinicaltrials.gov, this research is actively searching for participants to join its ranks. It was initially shared online on May 7th 2019 and recently updated February 3rd 2022."
Answered by AI
What indications is Brentuximab Vedotin regularly used to treat?
"As a first line of defense against Hodgkin's Disease, brentuximab vedotin is typically prescribed. It may also be beneficial for patients with systemic anaplastic large cell lymphoma and peripheral T-Cell Lymphoma who have yet to receive treatment."
Answered by AI
Has the U.S. Food and Drug Administration granted authorization for Brentuximab Vedotin?
"Brentuximab Vedotin, which is in its second phase of clinical trials, achieved a score of 2 due to the available evidence on safety but lack of data regarding efficacy."
Answered by AI
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