A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

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Regeneron Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: REGN88
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026519
6R88-RA-0803

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 4 patient groups, including a placebo group

Dose 1
Experimental group
Description:
Active dose
Treatment:
Drug: REGN88
Dose 2
Experimental group
Description:
Active dose
Treatment:
Drug: REGN88
Dose 3
Experimental group
Description:
Active 3
Treatment:
Drug: REGN88
Dose 4
Placebo Comparator group
Description:
Placebo dose
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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