A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01011959

Enrollment

Registered

2009-11-11

Start date

2008-12-31

Completion date

2009-08-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Detailed description

This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate. 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 not begin until enrollment in Part B is complete.

Interventions

BIOLOGICALREGN88

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo	10 weeks

Secondary

Measure	Time frame
To evaluate exploratory efficacy endpoints	over 10 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026