NCT01011959

Brief Summary

This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

24 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

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

September 30, 2013

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

November 10, 2009

Last Update Submit

September 27, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo

    10 weeks

Secondary Outcomes (1)

  • To evaluate exploratory efficacy endpoints

    over 10 weeks

Study Arms (6)

1

ACTIVE COMPARATOR

dose 1 vs. placebo

Biological: REGN88

2

ACTIVE COMPARATOR

dose 2 vs. placebo

Biological: REGN88

3

ACTIVE COMPARATOR

dose 3 vs. placebo

Biological: REGN88

4

ACTIVE COMPARATOR

dose 4 vs. placebo

Biological: REGN88

5

ACTIVE COMPARATOR

dose 5 vs. placebo

Biological: REGN88

6

ACTIVE COMPARATOR

dose 6 vs. placebo

Biological: REGN88

Interventions

REGN88BIOLOGICAL

This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.

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Eligibility Criteria

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

You may qualify if:

  • Patients with an established diagnosis of Rheumatoid Arthritis
  • Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks

You may not qualify if:

  • Persistent chronic or current active infections
  • Patients who have taken anakinra within 2 weeks
  • Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
  • Patients who have taken adalimumab within 6 weeks
  • Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
  • Patients who have taken leflunomide or rituximab within 6 months
  • Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
  • Significant arthritis or other medical condition that could interfere with study evaluations
  • Participation in any clinical research study evaluating another investigational drug within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Santa Maria, California, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Delray Beach, Florida, United States

Location

Unknown Facility

Palm Harbor, Florida, United States

Location

Unknown Facility

Idaho Falls, Idaho, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Lansing, Michigan, United States

Location

Unknown Facility

Flowood, Mississippi, United States

Location

Unknown Facility

Kalamzaoo, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Reno, Nevada, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Orangeburg, South Carolina, United States

Location

Unknown Facility

Hixson, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, 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, MD

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 30, 2013

Record last verified: 2011-06

Locations

US(24)