A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis (RA)MedDRA version: 18.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-003033-26-BE
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
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 (according to the 2010 European League Against Rheumatism [EULAR]/American College of Rheumatology [ACR] classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
• Treated with and tolerating MTX
• Active RA as defined, for the purpose of this study, by persistent disease activity with at least 6 swollen and 6 tender joints (66/68-joint count), at the time of screening and baseline, and C-reactive protein (CRP) = 1.2 x upper limit of normal (ULN) at screening.
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
The main criteria for exclusion include the following:
• Have been treated with DMARDs/systemic immunosuppressives other than MTX, during the 4 weeks or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
• Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
• For subjects who received prior rituximab, subjects with an inadequate recovery of B cells should be excluded regardless of when they received rituximab.
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. ;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.;Primary end point(s): Reduction of signs and symptoms of RA;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - ACR20, ACR50, and ACR70 response over time.<br>- 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).<br>- EULAR DAS28 response (good, moderate, or no response).<br>- Remission using disease remission parameters: DAS28, SDAI, CDAI, Boolean.<br>- Health Assessment Questionnaire-Disability Index (HAQ-DI).<br>- Physical and mental component scores of Short Form Health Survey (SF-36). <br>- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).<br><br>- Pharmacokinetics<br><br>- Pharmacodynamics<br><br>- Safety<br><br>- Immunogenicity;Timepoint(s) of evaluation of this end point: 24 weeks evaluation for secondary endopoints mentioned bove (first 7 bullet points)<br><br>PK: 24 weeks<br><br>PD, safety and immunogenicity: For the complete duration of the study