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CompletedNCT01055899Updated Sep 30, 2013

Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

A Phase 1 interventional study of REGN88 and REGN88 in Rheumatoid Arthritis, sponsored by Regeneron Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-30.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.

Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • RA
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 15 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female ≥ 18 years of age
  2. Subjects must weigh > 50 kg and \< 100 kg
  3. 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
  4. 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
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. A history of Listeriosis or active tuberculosis (TB)
  2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
  3. History of prior articular or prosthetic joint infection
  4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
  5. 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
  6. Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Dose 1

    First dose of SC REGN88

    Biological: REGN88

  • Experimental
    Dose 2

    Second dose of SC REGN88

    Biological: REGN88

  • Experimental
    Dose 3

    Third dose of SC REGN88

    Biological: REGN88

Interventions

  • BiologicalREGN88

    Single SC Dose

  • BiologicalREGN88

    Single SC Dose

  • BiologicalREGN88

    Single SC Dose

06

What researchers measure

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

    Time frame: 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

    Time frame: 113 days

07

Study locations

2 sites
  • Duncansville, Pennsylvania, United States
  • Dallas, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01055899
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Jan 26, 2010
Start date
Jul 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Sep 30, 2013

Study contacts

Allen Radin, M.D.
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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