Rheumatoid ArthritisPhase 1NCT01850680
Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
A Phase 1 study testing sarilumab SAR153191 (REGN88), methotrexate and folic acid in people with Rheumatoid Arthritis, run by Sanofi at 2 sites in Japan.
Trial summary
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- sarilumab SAR153191 (REGN88), methotrexate and folic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesJapan
- Study dates
- Apr 2013to Dec 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Japanese who are 20 to 65 years of age
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
- Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit
Who cannot join
- Autoimmune or inflammatory systemic or localized joint disease other than RA
- Women of a positive pregnancy test
- Latent or active tuberculosis
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
- Treatment with anti-TNF agents, as follows:
- Etanercept: within 28 days prior to randomization
Show all 12Show fewer
- Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
- Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)
- Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study.
- Received surgery within 4 weeks prior to the screening visit or planned surgery during the study
- History of a systemic hypersensitivity reaction
- 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
2 sites in 1 country.
Japan2 sites
Investigational Site Number 392001
Sendai
Investigational Site Number 392002
Sendai
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate
Primary Objective:
To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate.
Secondary Objective:
To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
Read the detailed description
Total study duration per patient is up to 88 days
- Screening: 3 to 28 days
- Treatment: 1 day
- Follow-up: 57± 3 days after dosing
- Conditions
- Rheumatoid Arthritis
- Being tested
- sarilumab SAR153191 (REGN88), placebo, methotrexate, folic acid
- 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
placeboDrug
Pharmaceutical form:solution Route of administration: subcutaneous
methotrexateDrug
Pharmaceutical form:capsule Route of administration: oral
folic acidDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab (SAR153191, REGN88) Dose 1 | Experimental | First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy Receives: Drug: sarilumab SAR153191 (REGN88); Drug: methotrexate; Drug: folic acid |
| Sarilumab (SAR153191, REGN88) Dose 2 | Experimental | Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy Receives: Drug: sarilumab SAR153191 (REGN88); Drug: methotrexate; Drug: folic acid |
| Sarilumab (SAR153191, REGN88) Dose 3 | Experimental | Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy Receives: Drug: sarilumab SAR153191 (REGN88); Drug: methotrexate; Drug: folic acid |
| Sarilumab (SAR153191, REGN88) Dose 4 | Experimental | Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy Receives: Drug: sarilumab SAR153191 (REGN88); Drug: methotrexate; Drug: folic acid |
| Placebo Dose 5 | Placebo comparator | Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy Receives: Drug: placebo; Drug: methotrexate; Drug: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
Measured: Up to 88 days or end-of-study (EoS)
Assessment of the occurrence of anti-sarilumab antibodies
Measured: Day 1, Day 15, Day 29, Day 57
Assessment of the titer of anti-sarilumab antibodies
Measured: Day 1, Day 15, Day 29, Day 57
Secondary outcomes (3)
Assessment of PK parameter - maximum concentration (Cmax)
Measured: At each visit, up to 88 days
Assessment of PK parameter - area under curve (AUC)
Measured: At each visit, up to 88 days
Assessment of PK parameter - time to maximum concentration (tmax)
Measured: At each visit, up to 88 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 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
- NCT01850680
- Sponsor's protocol ID
- TDU13402
- Other IDs
- U1111-1134-0048
- Status last verified
- Jan 2014
- First submitted
- 1 May 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate
- ClinicalTrials.gov ID
- NCT01850680
- Acronym / sponsor ID
- TDU13402
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 May 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 assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate.
Secondary Objective:
To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
Detailed description
Total study duration per patient is up to 88 days
- Screening: 3 to 28 days
- Treatment: 1 day
- Follow-up: 57± 3 days after dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sarilumab (SAR153191, REGN88) Dose 1 | Experimental | Drug: sarilumab SAR153191 (REGN88), Drug: methotrexate, Drug: folic acidFirst dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy |
| Sarilumab (SAR153191, REGN88) Dose 2 | Experimental | Drug: sarilumab SAR153191 (REGN88), Drug: methotrexate, Drug: folic acidSecond dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy |
| Sarilumab (SAR153191, REGN88) Dose 3 | Experimental | Drug: sarilumab SAR153191 (REGN88), Drug: methotrexate, Drug: folic acidThird dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy |
| Sarilumab (SAR153191, REGN88) Dose 4 | Experimental | Drug: sarilumab SAR153191 (REGN88), Drug: methotrexate, Drug: folic acidFourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy |
| Placebo Dose 5 | Placebo comparator | Drug: placebo, Drug: methotrexate, Drug: folic acidPlacebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female Japanese who are 20 to 65 years of age
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
- Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit
Key exclusion criteria (12 listed)
- Autoimmune or inflammatory systemic or localized joint disease other than RA
- Women of a positive pregnancy test
- Latent or active tuberculosis
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
- Treatment with anti-TNF agents, as follows:
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 | Drug | Sarilumab (SAR153191, REGN88) Dose 1, Sarilumab (SAR153191, REGN88) Dose 2, Sarilumab (SAR153191, REGN88) Dose 3, Sarilumab (SAR153191, REGN88) Dose 4 |
| placeboPharmaceutical form:solution Route of administration: subcutaneous | Drug | Placebo Dose 5 |
| methotrexatePharmaceutical form:capsule Route of administration: oral | Drug | Placebo Dose 5, Sarilumab (SAR153191, REGN88) Dose 1, Sarilumab (SAR153191, REGN88) Dose 2, Sarilumab (SAR153191, REGN88) Dose 3, Sarilumab (SAR153191, REGN88) Dose 4 |
| folic acidPharmaceutical form:tablet Route of administration: oral | Drug | Placebo Dose 5, Sarilumab (SAR153191, REGN88) Dose 1, Sarilumab (SAR153191, REGN88) Dose 2, Sarilumab (SAR153191, REGN88) Dose 3, Sarilumab (SAR153191, REGN88) Dose 4 |
Primary outcome
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
Time frame: Up to 88 days or end-of-study (EoS)
Assessment of the occurrence of anti-sarilumab antibodies
Time frame: Day 1, Day 15, Day 29, Day 57
Assessment of the titer of anti-sarilumab antibodies
Time frame: Day 1, Day 15, Day 29, Day 57
3 secondary outcomes
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: At each visit, up to 88 days
Assessment of PK parameter - area under curve (AUC)
Time frame: At each visit, up to 88 days
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: At each visit, up to 88 days
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 Jan 2014.
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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
2 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), methotrexate and folic acid in people with Rheumatoid Arthritis, run by Sanofi at 2 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 12 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) (time frame: Up to 88 days or end-of-study (EoS)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2014.