NCT01026519

Brief Summary

This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.

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 Sep 2008

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

September 30, 2013

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

December 2, 2009

Last Update Submit

September 27, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • hs-C reactive protein (hs-CRP)

    43 Days

Secondary Outcomes (1)

  • Subject's Assessment of Pain and Subject's Global Assessment of Disease activity

    43 Days

Study Arms (4)

Dose 1

EXPERIMENTAL

Active dose

Drug: REGN88

Dose 2

EXPERIMENTAL

Active dose

Drug: REGN88

Dose 3

EXPERIMENTAL

Active 3

Drug: REGN88

Dose 4

PLACEBO COMPARATOR

Placebo dose

Other: Placebo

Interventions

REGN88DRUG

Single dose of REGN88 and 43 day follow up.

Dose 1Dose 2Dose 3
PlaceboOTHER

Placebo to match REGN88 administration

Dose 4

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 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Rheumatology under the Russian Academy of Medical Sciences

Moscow, Russia

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, MD

    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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 4, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

September 30, 2013

Record last verified: 2011-06

Locations

RU(1)