Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients
NCT ID: NCT02089087
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2013-01-07
2017-02-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CFZ533 in healthy volunteers
CFZ533 single dose in healthy volunteers
CFZ533
Single dose at varying dosage levels depending on treatment assignment
CFZ533 in rheumatoid arthritis patients
CFZ533 single dose in rheumatoid arthritis patients
CFZ533
Single dose at varying dosage levels depending on treatment assignment
Placebo
Placebo single dose
Placebo
Interventions
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CFZ533
Single dose at varying dosage levels depending on treatment assignment
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits
3. Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2
1. Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age
2. Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator
3. Treatment with a stable oral RA treatment regimen for ≥ 4 weeks before randomization
4. Systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization
5. Subjects taking NSAIDs (COX-1 or COX-2 inhibitors) as part of their RA therapy must be on a stable dose for at least 4 weeks before randomization
Exclusion Criteria
2. Abnormal hematology, coagulation or inflammatory lab results
3. History or evidence of tuberculosis.
1. Use of anti-TNF or other biologics in previous 3 months
2. Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization
3. Previous treatment with a B cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved)
4. Current treatment with cyclophosphamide
5. Autoimmune disease other than RA
6. Adult juvenile rheumatoid arthritis
7. RA functional status class IV according to the ACR 1991 revised criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
South Miami, Florida, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Taipei, , Taiwan
Countries
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References
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Espie P, He Y, Koo P, Sickert D, Dupuy C, Chokote E, Schuler R, Mergentaler H, Ristov J, Milojevic J, Verles A, Groenewegen A, Auger A, Avrameas A, Rotte M, Colin L, Tomek CS, Hernandez-Illas M, Rush JS, Gergely P. First-in-human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti-CD40 monoclonal antibody. Am J Transplant. 2020 Feb;20(2):463-473. doi: 10.1111/ajt.15661. Epub 2019 Dec 6.
Related Links
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Results for CCFZ533X2101 from the Novartis Trial Results database
A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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CCFZ533X2101
Identifier Type: -
Identifier Source: org_study_id