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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005017-45 | EudraCT Number |
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This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis
The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1). Patients will receive NI-0101 or placebo infusions up to a maximum of 6 administrations (every two weeks for 12 weeks). All patients will continue receiving a stable dose of MTX. After 12 weeks, patients will enter the follow up period with monthly visits for a minimum of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NI-0101 | Experimental | A therapeutic humanized monoclonal antibody, administered by intravenous infusion every 2 weeks. |
|
| Placebo | Placebo Comparator | The placebo matches NI-0101 without active ingredient, administered by intravenous infusion every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NI-0101 | Drug | Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody targeting TLR4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, causality and outcomes of Adverse Events (AEs) | Incidence, severity, causality and outcomes of Adverse Events (AEs) (serious and non-serious), with particular attention being paid to infusion-related reactions and infections | From screening up to 24 weeks after first treatment administration |
| Withdrawal for safety reasons | From randomization up to 24 weeks after first treatment administration | |
| Evolution of laboratory parameters | From screening up to 24 weeks after first treatment administration | |
| Level of potential circulating antibodies against NI-0101 | Level of potential circulating antibodies against NI-0101 to determine immunogenicity; i.e. the development of anti-drug antibodies (ADA). | From screening up to 24 weeks after first treatment administration |
| Levels of CRP | Levels of C-Reactive protein (CRP) | From screening up to 24 weeks after first treatment administration |
| Levels of inflammatory cytokines/chemokines | IL-6, TNFa, IP-10, MCP-1, sICAM, CXCL13 | From screening up to 24 weeks after first treatment administration |
| DAS28 CRP | Measure of Disease Activity Scores (DAS) for Rheumatism in 28 tender or swollen joints and C-Reactive protein (CRP) - DAS28-CRP | From screening to 24 weeks after first treatment administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernest Choy, MD | Institute of Infection and Immunity, Cardiff University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for internal medicine with centre for dialysis | Mostar | 88000 | Bosnia and Herzegovina | |||
| Multi-profile Hospital for Active Treatment "Trimontsium" |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000619441 | NI-0101 |
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| Placebo |
| Other |
Placebo |
|
| ACR criteria | Proportion of patients achieving American College of Rheumatology Criteria (ACR20, ACR50 and ACR70) | From randomization to 24 weeks after first treatment administration |
| Proportion of patient achieving remission | Proportion of patient achieving remission (defined as DAS28 < 2.6) | From randomization to 24 weeks after first treatment administration |
| EULAR response | Proportion of patients achieving European League Against Rheumatism (EULAR) response criteria - good, moderate and no response | From randomization to 24 weeks after first treatment administration |
| Joint Count | Mean number of Tender Joint Count/Swollen Joint Count. | From screening to 24 weeks after first treatment administration |
| SDAI score | Mean improvement from baseline in Simplified Disease Activity Index (SDAI) score | From randomization to 24 weeks after first treatment administration |
| HAQ-DI score | Mean improvement from baseline in the Health Assessment Questionnaire without Disability Index (HAQ-DI) score | From randomization to 24 weeks after first treatment administration |
| SF-36 score | Mean improvement from baseline in 36-Item Short-Form Health Survey (SF-36) score | from randomization to 24 weeks after first treatment administration |
| DAS28-ESR | Measure of Disease Activity Scores (DAS) for Rheumatism in 28 tender or swollen joints and Erythrocyte Sedimentation Rate (ESR) levels - DAS28-ESR | From screening to 24 weeks after first treatment administration |
| CDAI score | Mean improvement from baseline in Clinical Disease Activity Index (CDAI) score scores | From randomization to 24 weeks after first treatment administration |
| Exploratory PK analysis - Cmax | Peak drug plasma concentration (Cmax) | From randomization to 24 weeks after first treatment administration |
| Exploratory PK analysis - Tmax | Time when plasma concentration is at peak (Tmax) | From screening up to 24 weeks after first treatment administration |
| Exploratory PK analysis - Ctrough | Plasma drug concentration immediately prior next dosing (Ctrough) | From randomization to 24 weeks after first treatment administration |
| Exploratory PK analysis - AUC | Area under the plasma concentration versus time curve (AUC) | From randomization to 24 weeks after first treatment administration |
| Exploratory PK analysis - CL | Systemic drug clearance (CL) | From randomization to 24 weeks after first treatment administration |
| Plovdiv |
| 4000 |
| Bulgaria |
| University Multiprofile Hospital for Active Treatment "Kaspela" | Plovdiv | 4001 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Shumen AD | Shumen | 9705 | Bulgaria |
| University Multiprofile Hospital for Active TreatmenT "St. Ivan Rilski" | Sofia | 1612 | Bulgaria |
| ARENSIA Phase I Unit at the Research Institute of Clinical Medicine | Tbilisi | 0112 | Georgia |
| High Technology Medical Center; University clinic | Tbilisi | 0144 | Georgia |
| Emergency Cardiology Center by Acad. G.Chapidze | Tbilisi | 0159 | Georgia |
| Insitute of Clinical Cardiology | Tbilisi | 0159 | Georgia |
| Tbilisi Central Hospital | Tbilisi | 0159 | Georgia |
| Multiprofile Clinic Consilium Medulla | Tbilisi | 0186 | Georgia |
| CRU Hungary Ltd | Miskolc | 3529 | Hungary |
| Republican Clinical Hospital, ARENSIA Phase I unit | Chisinau | MD2025 | Moldova |
| Centrum Miriada | Bialystok | 15-297 | Poland |
| Zespól Poradni Specjalistycznych REUMED | Lublin | 20-582 | Poland |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Special Hospital for Rheumatic Diseases "Novi Sad" | Novi Sad | 21112 | Serbia |
| General Hospital "Djordje Joanovic" | Zrenjanin | 23000 | Serbia |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |