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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT02089087
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: CFZ533 Drug: Placebo Phase 1

Detailed Description:
This was a Healthy Volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now registered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : February 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CFZ533 in healthy volunteers
CFZ533 single dose in healthy volunteers
Biological: CFZ533
Single dose at varying dosage levels depending on treatment assignment

Experimental: CFZ533 in rheumatoid arthritis patients
CFZ533 single dose in rheumatoid arthritis patients
Biological: CFZ533
Single dose at varying dosage levels depending on treatment assignment

Placebo Comparator: Placebo
Placebo single dose
Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 6 months ]

    The following PK parameters were determined from the plasma concentration time profile of CFZ533 using a non-compartmental method:

    AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval

    AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

    AUCinf: Area under the plasma concentration-time curve from time zero to infinity


  2. Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax) [ Time Frame: 6 months ]
  3. Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL) [ Time Frame: 6 months ]
  4. Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss) [ Time Frame: 6 months ]
  5. CFZ533 immunogenicity [ Time Frame: 6 months ]
    Determining the presence and measuring amount of anti-CFZ533 antibodies in the blood



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (for healthy volunteers):

  1. Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age (for Cohort 9 only, subjects must be of Chinese descent)
  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

Inclusion Criteria (for rheumatoid arthritis patients):

  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 (for healthy volunteers):

  1. History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents)
  2. Abnormal hematology, coagulation or inflammatory lab results
  3. History or evidence of tuberculosis.

Exclusion Criteria (for rheumatoid arthritis patients):

  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

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089087


Locations
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United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
South Miami, Florida, United States, 33143
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68502
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 110
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02089087     History of Changes
Other Study ID Numbers: CCFZ533X2101
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Rheumatoid arthritis, RA, first-in-human, single ascending dose, safety, tolerability

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases