Rheumatoid Arthritis (RA) MedDRA version: 18.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
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)/mi
Sponsors
Ablynx NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main criteria for inclusion include the following: • Man or woman = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Argentina, Belgium, Bulgaria, Czech Republic, Georgia, Germany, Hungary, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain, United States
Contacts
Public ContactRegulatory Affairs Lead
Worldwide Clinical Trials Ltd
Outcome results
None listed