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

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003034-42-HU

Enrollment

501

Registered

2015-03-03

Start date

2015-05-08

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

Rheumatoid Arthritis (RA) MedDRA version: 18.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: ALX-0061 Product Code: ALX-0061 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available CAS Number: 1628814-88-9 Other descriptive name: ALX-0061 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active RA.;Secondary Objective: Not applicable;Primary end point(s): - ACR20, ACR50, and ACR70 response over time. - Disease activity: Disease Activity Score using 28 joint counts (DAS28 using CRP and erythrocyte sedimentation rate [ESR]), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI). - EULAR DAS28 response (good, moderate, or no response). - Remission using disease remission parameters: DAS28, SDAI, CDAI, Boolean. - Health Assessment Questionnaire-Disability Index (HAQ-DI). - Physical and mental component scores of Short Form Health Survey (SF-36). - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Pharmacokinetics: • Determination of ALX-0061 serum levels. Safety: • Safety assessments will include: - Physical examinations. - Vital sign measurements - Clinical laboratory assessments - Adverse events Immunogenicity: • Determination of anti-ALX-0061 antibodies (ADA) ;Timepoint(s) of evaluation of this end point: Up to 104 weeks evaluation for secondary endopoints mentioned bove (first 7 bullet points) Pharmacokinetics: up to 104 weeks Safety: up to 114 weeks Immunogenicity: up to 114 weeks	—

Measure

Time frame

Main Objective: To evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active RA.;Secondary Objective: Not applicable;Primary end point(s): - ACR20, ACR50, and ACR70 response over time. - Disease activity: Disease Activity Score using 28 joint counts (DAS28 using CRP and erythrocyte sedimentation rate [ESR]), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI). - EULAR DAS28 response (good, moderate, or no response). - Remission using disease remission parameters: DAS28, SDAI, CDAI, Boolean. - Health Assessment Questionnaire-Disability Index (HAQ-DI). - Physical and mental component scores of Short Form Health Survey (SF-36). - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Pharmacokinetics: • Determination of ALX-0061 serum levels. Safety: • Safety assessments will include: - Physical examinations. - Vital sign measurements - Clinical laboratory assessments - Adverse events Immunogenicity: • Determination of anti-ALX-0061 antibodies (ADA) ;Timepoint(s) of evaluation of this end point: Up to 104 weeks evaluation for secondary endopoints mentioned bove (first 7 bullet points) Pharmacokinetics: up to 104 weeks Safety: up to 114 weeks Immunogenicity: up to 114 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Argentina, Belgium, Bulgaria, Czech Republic, Georgia, Germany, Hungary, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain

Contacts

Public ContactRegulatory Affairs Lead

Worldwide Clinical Trials Ltd

sm_ra_admin@wwctrials.com+44207121 6161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026