Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 September 2018 |
Main ID: |
EUCTR2014-003034-42-HU |
Date of registration:
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03/03/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis
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Scientific title:
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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:
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08/05/2015 |
Target sample size:
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501 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003034-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Belgium
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Bulgaria
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Czech Republic
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Georgia
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Germany
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Hungary
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Macedonia, the former Yugoslav Republic of
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Mexico
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Moldova, Republic of
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Poland
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Romania
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Serbia
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Spain
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Contacts
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Name:
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Regulatory Affairs Lead
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Address:
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2nd Floor, 172 Tottenham Court Road
W1T 7NS
London
United Kingdom |
Telephone:
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+44207121 6161 |
Email:
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sm_ra_admin@wwctrials.com |
Affiliation:
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Worldwide Clinical Trials Ltd |
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Name:
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Regulatory Affairs Lead
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Address:
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2nd Floor, 172 Tottenham Court Road
W1T 7NS
London
United Kingdom |
Telephone:
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+44207121 6161 |
Email:
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sm_ra_admin@wwctrials.com |
Affiliation:
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Worldwide Clinical Trials Ltd |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Rheumatoid Arthritis (RA) MedDRA version: 18.1
Level: SOC
Classification code 10021428
Term: Immune system disorders
System Organ Class: 10021428 - Immune system disorders
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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Secondary Objective: Not applicable
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Main Objective: To evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active RA.
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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)
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Secondary Outcome(s)
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Secondary end point(s): Not Applicable
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Timepoint(s) of evaluation of this end point: Not Applicable
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Secondary ID(s)
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ALX0061-C203
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Source(s) of Monetary Support
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Ablynx NV
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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