Rheumatoid ArthritisPhase 1NCT01328522
Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
A Phase 1 study testing SAR153191 (REGN88) in people with Rheumatoid Arthritis, run by Sanofi at 4 sites in United States.
Trial summary
Primary Objective: Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients. Secondary Objective: Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose… 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?
- SAR153191 (REGN88)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2011to Sep 2011
- 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
- Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration.
- Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.
Who cannot join
- Autoimmune disease other than RA.
- History of acute inflammatory joint disease other than RA.
- Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
- Latent or active tuberculosis.
- Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
- Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
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- Received tuberculosis vaccination within 12 months prior to screening
- Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
- Known latex sensitivity.
- 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
4 sites in 1 country.
United States4 sites
Investigational Site Number 840003
Beverly Hills, California, 90211
Investigational Site Number 840002
Dallas, Texas, 75235
Investigational Site Number 840004
Duncansville, Pennsylvania, 16635
Investigational Site Number 840001
Ocala, Florida, 34471
About this study
Primary Objective:
Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Secondary Objective:
Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Read the detailed description
The duration of the study period per subject is 5-7 weeks broken down as follows:
- Screening: 1 to 14 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).
- Conditions
- Rheumatoid Arthritis
- Being tested
- SAR153191 (REGN88)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR153191 (REGN88)Drug
Pharmaceutical form:solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR153191 drug product 1 | Experimental | SAR153191 drug product 1 in a single injection.
Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. Receives: Drug: SAR153191 (REGN88) |
| SAR153191 drug product 2 | Experimental | SAR153191 drug product 2 in a single injection.
Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. Receives: Drug: SAR153191 (REGN88) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
Measured: 5 weeks
Occurrence of Adverse Events
Measured: 5 weeks
Secondary outcomes (5)
Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire
Measured: 2 days
Pain evaluation using Visual Analog Scale (VAS)
Measured: 2 days
Diameter of the erythema at injection site
Measured: 2 days
Diameter of the edema at injection site
Measured: 2 days
Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 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
- NCT01328522
- Sponsor's protocol ID
- PKM12058
- Other IDs
- U1111-1119-2883
- Status last verified
- Oct 2011
- First submitted
- 31 Mar 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01328522
- Acronym / sponsor ID
- PKM12058
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Apr 2011 (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:
Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Secondary Objective:
Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Detailed description
The duration of the study period per subject is 5-7 weeks broken down as follows:
- Screening: 1 to 14 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR153191 drug product 1 | Experimental | Drug: SAR153191 (REGN88)SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. |
| SAR153191 drug product 2 | Experimental | Drug: SAR153191 (REGN88)SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration.
- Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.
Key exclusion criteria (10 listed)
- Autoimmune disease other than RA.
- History of acute inflammatory joint disease other than RA.
- Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
- Latent or active tuberculosis.
- Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
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 |
|---|---|---|
| SAR153191 (REGN88)Pharmaceutical form:solution Route of administration: subcutaneous | Drug | SAR153191 drug product 1, SAR153191 drug product 2 |
Primary outcome
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
Time frame: 5 weeks
Occurrence of Adverse Events
Time frame: 5 weeks
5 secondary outcomes
Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire
Time frame: 2 days
Pain evaluation using Visual Analog Scale (VAS)
Time frame: 2 days
Diameter of the erythema at injection site
Time frame: 2 days
Diameter of the edema at injection site
Time frame: 2 days
Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)
Time frame: 5 weeks
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 24 Oct 2011.
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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
4 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 SAR153191 (REGN88) in people with Rheumatoid Arthritis, run by Sanofi at 4 sites in United States.
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 2 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 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results (time frame: 5 weeks). The study lists 2 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 24 Oct 2011.