A Phase IIb Study for ALX-0061 Monotherapy in Subjects with 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: EUCTR2014-003012-36-HU
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-30
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

•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.
•Received previous or current treatment with MTX, and is considered intolerant to MTX, or for whom continued treatment with MTX is considered inappropriate, or have contraindications for MTX use.
•Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
•Active RA
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 217
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

•Have been treated with DMARDs/systemic immunosuppressive prior to first administration of study drug.
•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 (including JAK inhibitors), for RA.
•Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.

Study & Design

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