A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis (RA); MedDRA version: 18.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003033-26-BG
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-19
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

The main criteria for inclusion include the following:
• Man or woman = 18 years and < 75 years of age at the time of signing the informed consent form.
• Diagnosis of RA for at least 6 months prior to screening, and ACR functional class I-III.
• Treated with and tolerating MTX
• Active RA

A complete list of selection criteria can be found in the body of the Clinical Study Protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

The main criteria for exclusion include the following:
• 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. For subjects who received prior rituximab, subjects with an inadequate recovery of B cells should be excluded regardless of when they received
rituximab.
• 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.

A complete list of selection criteria can be found in the body of the Clinical Study Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified