Rheumatoid ArthritisPhase 1NCT02404558
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
A Phase 1 study testing sarilumab SAR153191 (REGN88) and tocilizumab in people with Rheumatoid Arthritis, run by Sanofi at 3 sites in Japan.
Trial summary
Primary Objective: To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- sarilumab SAR153191 (REGN88) and tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesJapan
- Study dates
- May 2015to Mar 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
- Rheumatoid Arthritis Classification Criteria.
- ACR Class I-III functional status, based on the 1991 revised criteria.
Who cannot join
- Patients less than 20 years of age.
- Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
- Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
- Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
- Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.
- Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.
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- Active or suspected tuberculosis (TB) or at high risk of contracting TB.
- Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational Site Number 392001
Sendai
Investigational Site Number 392002
Sendai
Investigational Site Number 392003
Sendai
About this study
Official title: An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
Primary Objective:
To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).
Secondary Objectives:
To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.
To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
Read the detailed description
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
- Conditions
- Rheumatoid Arthritis
- Being tested
- sarilumab SAR153191 (REGN88), tocilizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarilumab SAR153191 (REGN88)Drug
Pharmaceutical form:solution Route of administration: Subcutaneous injection
tocilizumabDrug
Pharmaceutical form:solution Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab | Experimental | Single subcutaneous (SC) dose of sarilumab Receives: Drug: sarilumab SAR153191 (REGN88) |
| Tocilizumab | Active comparator | Single SC dose of tocilizumab Receives: Drug: tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with adverse events
Measured: 6 weeks
Percentage of patients with potentially clinically significant laboratory abnormalities
Measured: 6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)
Measured: Baseline, Day 15
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Measured: Baseline, Day 15
Secondary outcomes (5)
Assessment of PK parameter: maximum concentration (Cmax)
Measured: Day 1 to Day 43
Assessment of PK parameter: time to Cmax (tmax)
Measured: Day 1 to Day 43
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Measured: Day 1 to Day 43
Change from baseline in laboratory parameters (hematology and biochemistry)
Measured: Baseline, Day 29 and Day 43
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Measured: Baseline, Day 29 and Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
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 SanofiThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404558
- Sponsor's protocol ID
- PDY14191
- Other IDs
- U1111-1163-1359
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2015
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.
PubMed 32453485
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02404558
- Acronym / sponsor ID
- PDY14191
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Mar 2015 (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.
Primary Objective:
To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).
Secondary Objectives:
To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.
To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
Detailed description
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarilumab | Experimental | Drug: sarilumab SAR153191 (REGN88)Single subcutaneous (SC) dose of sarilumab |
| Tocilizumab | Active comparator | Drug: tocilizumabSingle SC dose of tocilizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
- Rheumatoid Arthritis Classification Criteria.
- ACR Class I-III functional status, based on the 1991 revised criteria.
Key exclusion criteria (9 listed)
- Patients less than 20 years of age.
- Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
- Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
- Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
- Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to 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 |
|---|---|---|
| sarilumab SAR153191 (REGN88)Pharmaceutical form:solution Route of administration: Subcutaneous injection | Drug | Sarilumab |
| tocilizumabPharmaceutical form:solution Route of administration: Subcutaneous injection | Drug | Tocilizumab |
Primary outcome
Percentage of patients with adverse events
Time frame: 6 weeks
Percentage of patients with potentially clinically significant laboratory abnormalities
Time frame: 6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 15
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 15
5 secondary outcomes
Assessment of PK parameter: maximum concentration (Cmax)
Time frame: Day 1 to Day 43
Assessment of PK parameter: time to Cmax (tmax)
Time frame: Day 1 to Day 43
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Time frame: Day 1 to Day 43
Change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 29 and Day 43
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time frame: Baseline, Day 29 and Day 43
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 28 Mar 2016.
- Derived from this study: PubMed 32453485Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.
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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.
Clinical Sciences & Operations study director
Sanofi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sarilumab SAR153191 (REGN88) and tocilizumab in people with Rheumatoid Arthritis, run by Sanofi at 3 sites in Japan.
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 3 inclusion and 9 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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. 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?
Percentage of patients with adverse events (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT02404558, 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 28 Mar 2016.