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

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2014-003034-42-ES
• Date of registration: 14/04/2015
• Prospective Registration: Yes
• Primary sponsor: Ablynx NV
• Public title: An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis
• Scientific title: 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
• Date of first enrolment: 19/06/2015
• Target sample size: 501
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003034-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Regulatory Affairs Lead
• Affiliation: Worldwide Clinical Trials Ltd

• Name: Regulatory Affairs Lead
• Affiliation: Worldwide Clinical Trials Ltd

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis (RA)
MedDRA version: 18.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Intervention(s)

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 unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Secondary Objective: Not applicable

Main Objective: To evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active RA.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary end point(s): Not Applicable

Secondary ID(s)

ALX0061-C203

2014-003034-42-HU

Source(s) of Monetary Support

Ablynx NV