NCT01328522

Brief 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 administration in rheumatoid arthritis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2011

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 24, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

March 31, 2011

Last Update Submit

October 21, 2011

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Occurrence of potentially clinically significant abnormalities in clinical laboratory test results

    5 weeks

  • Occurrence of Adverse Events

    5 weeks

Secondary Outcomes (5)

  • Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire

    2 days

  • Pain evaluation using Visual Analog Scale (VAS)

    2 days

  • Diameter of the erythema at injection site

    2 days

  • Diameter of the edema at injection site

    2 days

  • Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)

    5 weeks

Study Arms (2)

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.

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.

Drug: SAR153191 (REGN88)

Interventions

SAR153191 (REGN88)DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

SAR153191 drug product 1SAR153191 drug product 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • Received tuberculosis vaccination within 12 months prior to screening
  • Known latex sensitivity.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Investigational Site Number 840003

Beverly Hills, California, 90211, United States

Location

Investigational Site Number 840001

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840004

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840002

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 24, 2011

Record last verified: 2011-10

Locations

US(4)