Rheumatoid ArthritisPhase 1NCT02089087
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients
A Phase 1 study testing CFZ533 in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CFZ533
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Jan 2013to 3 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
- Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits
- Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2
- Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age
- Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator
- Treatment with a stable oral RA treatment regimen for ≥ 4 weeks before randomization
- Systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization
- 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
Who cannot join
- History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents)
- Abnormal hematology, coagulation or inflammatory lab results
- History or evidence of tuberculosis.
- Use of anti-TNF or other biologics in previous 3 months
- Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization
- Previous treatment with a B cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved)
Show all 11Show fewer
- Current treatment with cyclophosphamide
- Autoimmune disease other than RA
- Adult juvenile rheumatoid arthritis
- RA functional status class IV according to the ACR 1991 revised criteria
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Novartis Investigative Site
Anniston, Alabama, 36207-5710
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
Lincoln, Nebraska, 68502
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
South Miami, Florida, 33143
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CFZ533, Placebo
- Keywords
- Rheumatoid arthritis, RA, first-in-human, single ascending dose, safety, tolerability
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFZ533Biological
Single dose at varying dosage levels depending on treatment assignment
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CFZ533 in healthy volunteers | Experimental | CFZ533 single dose in healthy volunteers Receives: Biological: CFZ533 |
| CFZ533 in rheumatoid arthritis patients | Experimental | CFZ533 single dose in rheumatoid arthritis patients Receives: Biological: CFZ533 |
| Placebo | Placebo comparator | Placebo single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety and tolerability
Measured: 7 months
Secondary outcomes (5)
Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC)
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
Measured: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Measured: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL)
Measured: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss)
Measured: 6 months
CFZ533 immunogenicity
Determining the presence and measuring amount of anti-CFZ533 antibodies in the blood
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start7 Jan 2013
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089087
- Sponsor's protocol ID
- CCFZ533X2101
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2014
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31647605
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089087
- Acronym / sponsor ID
- CCFZ533X2101
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, RA, first-in-human, single ascending dose, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CFZ533 in healthy volunteers | Experimental | Biological: CFZ533CFZ533 single dose in healthy volunteers |
| CFZ533 in rheumatoid arthritis patients | Experimental | Biological: CFZ533CFZ533 single dose in rheumatoid arthritis patients |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
- Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits
- Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2
- Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age
- Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator
Key exclusion criteria (11 listed)
- History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents)
- Abnormal hematology, coagulation or inflammatory lab results
- History or evidence of tuberculosis.
- Use of anti-TNF or other biologics in previous 3 months
- Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFZ533Single dose at varying dosage levels depending on treatment assignment | Biological | CFZ533 in healthy volunteers, CFZ533 in rheumatoid arthritis patients |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 7 months
5 secondary outcomes
Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC)
Time frame: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Time frame: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL)
Time frame: 6 months
Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss)
Time frame: 6 months
CFZ533 immunogenicity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 31647605Espie 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.
- Results for CCFZ533X2101 from the Novartis Trial Results databaseLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CFZ533 in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events as a measure of safety and tolerability (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.