A Phase IIb Study for ALX-0061 Monotherapy in Subjects with 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
- EUCTR2014-003012-36-CZ
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 228
•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.
•Received previous or current treatment with MTX, and is considered intolerant to MTX, or for whom continued treatment with MTX is considered inappropriate, or have contraindications for MTX use.
•Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
•Active RA
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 217
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
•Have been treated with DMARDs/systemic immunosuppressive 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 (including JAK inhibitors), for RA.
•Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.
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 monotherapy administered s.c. to subjects with active RA;Secondary Objective: To assess the effects of ALX-0061 on quality of life, PK, PD, and immunogenicity of ALX 0061 and to explore potential dose regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical development. <br><br>To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.<br>;Primary end point(s): The proportion of subjects achieving an ACR20 response at Week 12.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Time points for all secondary endpoints above are 12 weeks except Pharmacodynamics, Safety and Immunogenicity, the time point for which is 24 weeks;Secondary end point(s): -ACR20, ACR50, and ACR70 response over time.<br>-Disease activity: Disease Activity Score using 28 joint counts (DAS28<br>using CRP and erythrocyte sedimentation rate [ESR]), Simplified Disease<br>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,<br>Boolean.<br>-Health Assessment Questionnaire-Disability Index (HAQ-DI).<br>-Physical and mental component scores of Short Form Health Survey<br>(SF-36).<br>-Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue).<br>-Pharmacokinetics<br>-Pharmacodynamics<br>-Safety<br>-Immunogenicity