A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - 74
Updated:	9/7/2017
Start Date:	January 2015
End Date:	August 2016

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061
administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with
active RA despite MTX therapy, compared with placebo.

To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics
(PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,
based on safety and efficacy, for further clinical development.

Inclusion Criteria:

- Diagnosis of RA for at least 6 months prior to screening, and ACR functional class
I-III

- Subjects treated with and tolerating MTX

- Active RA

- Others as defined in the protocol

Exclusion Criteria:

- Have been treated with DMARDs/systemic immunosuppressives other than MTX.

- Have received approved or investigational biological or targeted synthetic DMARD
therapies for RA less than 6 months prior to screening.

- Have a history of toxicity, non-tolerance, primary non-response or inadequate response
to a biological therapy, or targeted synthetic DMARDs, for RA.

- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

- Others as defined in the protocol

We found this trial at

sites

Clinical Trial Facility in Homestead Florida

Homestead, Florida

1323

from

Homestead, FL