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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3 October 2016 |
Main ID: |
EUCTR2014-003033-26-ES |
Date of registration:
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07/01/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis
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Scientific title:
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A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy |
Date of first enrolment:
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20/02/2015 |
Target sample size:
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330 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003033-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 5
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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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United States
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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: The main criteria for inclusion include the following: ? 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. ? Treated with and tolerating MTX ? Active RA
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 314 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria: The main criteria for exclusion include the following: ? Have been treated with DMARDs/systemic immunosuppressives other than MTX. ? Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening. ? Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs for RA. ? Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.
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: 17.1
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 Other descriptive name: ALX-0061 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 12
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Primary end point(s): Reduction of signs and symptoms of RA
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Main Objective: ?To assess the efficacy and safety of dose regimens of ALX-0061 administered s.c. in combination with MTX to subjects with active RA despite MTX therapy compared with placebo.
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Secondary Objective: ?To assess the effects of ALX-0061 on quality of life, PK, PD, and immunogenicity of ALX 0061, and to define the optimal dose regimen for ALX 0061, based on safety and efficacy, for further clinical development.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 24 weeks evaluation for secondary endopoints mentioned bove (first 7 bullet points)
PK: 24 weeks
PD, safety and immunogenicity: For the complete duration of the study
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Secondary 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
- Pharmacodynamics
- Safety
- Immunogenicity
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Secondary ID(s)
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ALX0061-C201
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2014-003033-26-BE
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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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