NCT01055899

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
Last Updated

September 30, 2013

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

January 25, 2010

Last Update Submit

September 27, 2013

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate

    113 Days

Secondary Outcomes (1)

  • To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88

    113 days

Study Arms (3)

Dose 1

EXPERIMENTAL

First dose of SC REGN88

Biological: REGN88

Dose 2

EXPERIMENTAL

Second dose of SC REGN88

Biological: REGN88

Dose 3

EXPERIMENTAL

Third dose of SC REGN88

Biological: REGN88

Interventions

REGN88BIOLOGICAL

Single SC Dose

Dose 1

Eligibility Criteria

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

You may qualify if:

  • Male or female ≥ 18 years of age
  • Subjects must weigh \> 50 kg and \< 100 kg
  • Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
  • For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
  • For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full course of the study.

You may not qualify if:

  • A history of Listeriosis or active tuberculosis (TB)
  • Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
  • History of prior articular or prosthetic joint infection
  • History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
  • Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
  • Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, 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

  • Allen Radin, M.D.

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 30, 2013

Record last verified: 2011-06

Locations

US(2)