Rheumatoid ArthritisPhase 1NCT02017639
Sarilumab Effect on the Pharmacokinetics of Simvastatin
A Phase 1 study testing sarilumab SAR153191 (REGN88) and simvastatin in people with Rheumatoid Arthritis, run by Sanofi at 5 sites in 3 countries.
Trial summary
Primary Objective: To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis Secondary Objective: To describe the safety and efficacy (exploratory) of sarilumab Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- sarilumab SAR153191 (REGN88) and simvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2014to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 75 years of age, inclusive. Body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
- Diagnosis of RA, according to the ACR/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration, ACR Class I-III functional status, based on 1991 revised criteria (Appendix B, 5). Moderate-to-severely active RA, defined as:
- o high sensitivity C-reactive protein (hs-CRP) ≥ 6 mg/L
- Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for RA patients; however following lab values must be met:
- Hemoglobin >8.5 g/dL
- White blood cells >3000/mm3
- Neutrophils >2000/mm3
- Platelet count >150 000 cells/mm3
Who cannot join
- Prior or current significant concomitant illness(es) that, according to Investigator's judgment, would adversely affect the patient's participation in the study.
- Women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
- Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening, whichever is longer.
- Patients with active TB or a history of incompletely treated TB. History of chronic infection or active infection. History of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- A systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
- History or presence of drug or alcohol abuse. Prior or current interstitial lung disease diagnosed by high resolution computed tomography and/or lung biopsy with consistent findings on pulmonary function tests and corroborating clinical findings.
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- Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the screening visit.
- Uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) ≥9% at the screening visit.
- Current treatment with anti-TNF agents or other biologics. Current treatment with RA-directed biologic agents with non- TNF-α antagonist. Any contra-indications to simvastatin, according to the applicable labeling. Current treatment with a statin within 14 days before inclusion.
- 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
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Investigational Site Number 840001
Dallas, Texas, 75235
Investigational Site Number 840002
Duncansville, Pennsylvania, 16635
Investigational Site Number 840003
Jackson, Tennessee, 38305
About this study
Official title: A Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid Arthritis
Primary Objective:
To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis
Secondary Objective:
To describe the safety and efficacy (exploratory) of sarilumab
Read the detailed description
The duration of the entire study per patient completing both Parts A and B is expected to be approximately 58 weeks (not including Screening).
- Conditions
- Rheumatoid Arthritis
- Being tested
- sarilumab SAR153191 (REGN88), simvastatin
- 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:Prefilled syringe of sarilumab solution Route of administration: Subcutaneous injection
simvastatinDrug
Pharmaceutical form:Film-coated 20 mg Tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab SAR153191 (REGN88) | Experimental | Single dose of simvastatin before and after sarilumab administration Receives: Drug: sarilumab SAR153191 (REGN88); Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin
Measured: Day 1 of Period 1 and Day 8 of Period 2
Secondary outcomes (3)
Assessment of additional PK parameters for simvastatin
Measured: Day 1 of Period 1 and Day 8 of Period 2
Assessment of additional PK parameters for simvastatin acid
Measured: Day 1 of Period 1 and Day 8 of Period 2
Safety assessment of sarilumab up to 1 year )
Measured: From Day 1 of Period 1 up to a maximum of 1 year (week 58)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT02017639
- Sponsor's protocol ID
- INT12684
- Other IDs
- U1111-1140-5082
- Status last verified
- Apr 2016
- First submitted
- 2 Dec 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee EB, Daskalakis N, Xu C, Paccaly A, Miller B, Fleischmann R, Bodrug I, Kivitz A. Disease-Drug Interaction of Sarilumab and Simvastatin in Patients with Rheumatoid Arthritis. Clin Pharmacokinet. 2017 Jun;56(6):607-615. doi: 10.1007/s40262-016-0462-8.
PubMed 27722854
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02017639
- Acronym / sponsor ID
- INT12684
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Dec 2013 (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 evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis
Secondary Objective:
To describe the safety and efficacy (exploratory) of sarilumab
Detailed description
The duration of the entire study per patient completing both Parts A and B is expected to be approximately 58 weeks (not including Screening).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarilumab SAR153191 (REGN88) | Experimental | Drug: sarilumab SAR153191 (REGN88), Drug: simvastatinSingle dose of simvastatin before and after sarilumab administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, between 18 and 75 years of age, inclusive. Body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
- Diagnosis of RA, according to the ACR/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration, ACR Class I-III functional status, based on 1991 revised criteria (Appendix B, 5). Moderate-to-severely active RA, defined as:
- o high sensitivity C-reactive protein (hs-CRP) ≥ 6 mg/L
- Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for RA patients; however following lab values must be met:
- Hemoglobin >8.5 g/dL
Key exclusion criteria (10 listed)
- Prior or current significant concomitant illness(es) that, according to Investigator's judgment, would adversely affect the patient's participation in the study.
- Women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
- Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening, whichever is longer.
- Patients with active TB or a history of incompletely treated TB. History of chronic infection or active infection. History of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- A systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
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:Prefilled syringe of sarilumab solution Route of administration: Subcutaneous injection | Drug | Sarilumab SAR153191 (REGN88) |
| simvastatinPharmaceutical form:Film-coated 20 mg Tablet Route of administration: oral | Drug | Sarilumab SAR153191 (REGN88) |
Primary outcome
Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin
Time frame: Day 1 of Period 1 and Day 8 of Period 2
3 secondary outcomes
Assessment of additional PK parameters for simvastatin
Time frame: Day 1 of Period 1 and Day 8 of Period 2
Assessment of additional PK parameters for simvastatin acid
Time frame: Day 1 of Period 1 and Day 8 of Period 2
Safety assessment of sarilumab up to 1 year )
Time frame: From Day 1 of Period 1 up to a maximum of 1 year (week 58)
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 7 Apr 2016.
- Derived from this study: PubMed 27722854Lee EB, Daskalakis N, Xu C, Paccaly A, Miller B, Fleischmann R, Bodrug I, Kivitz A. Disease-Drug Interaction of Sarilumab and Simvastatin in Patients with Rheumatoid Arthritis. Clin Pharmacokinet. 2017 Jun;56(6):607-615. doi: 10.1007/s40262-016-0462-8.
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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
5 sites in 3 countries: 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 simvastatin in people with Rheumatoid Arthritis, run by Sanofi at 5 sites in 3 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 10 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Moldova, South Korea. 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?
Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin (time frame: Day 1 of Period 1 and Day 8 of Period 2). 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 NCT02017639, 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 7 Apr 2016.