An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis (RA); MedDRA version: 18.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003034-42-BE
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-18
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

• Must have been eligible for one of the preceding Phase IIb studies with
ALX-0061 (study ALX0061-C201 or ALX0061-C202), have been randomized to placebo or one of the ALX-0061 arms (subjects randomized to tocilizumab [TCZ] in study ALX0061-C202 are not eligible), and completed the entire treatment and assessment period of the preceding studies (i.e., 24 weeks for Study ALX0061-C201 and 12 weeks for Study ALX0061-C202).
• Must have reached at least 20% improvement in SJC and/or TJC (66/68 counts) at Week 24 for subjects participating in the preceding Phase IIb ALX0061-C201 study, or at Week 12 for subjects participating in the preceding Phase IIb ALX0061-C202 study.

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 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

The main criteria for exclusion include the following:
• Received TCZ during the previous Study ALX0061-C202.
• Received any prohibited treatment during the previous Phase IIb
• Diagnosis of or suspicion of a serious infection
• Diagnosis of malignancy or demyelinating disease during the preceding study.
• Any active or recurrent viral infection that based on the Investigator´s clinical assessment make the subject unsuitable for the study.
• Diagnosis of congestive heart failure (CHF) class III or IV, unstable angina pectoris, myocardial infarction, cerebrovascular accident during the preceding study.
• Abnormality in laboratory test results observed at the Week 22 Visit for subjects
participating in the preceding Phase IIb ALX0061-C201 study, or observed at the Week 10 Visit for subjects participating in the preceding Phase IIb ALX0061-C202 study.

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