E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Rheumatoid Arthritis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety, tolerability, and efficacy of ABBV-154 administered every other week (eow) and every 4 weeks (e4w) subcutaneously (SC) vs placebo in subjects with moderately to severely active RA with inadequate response to at least one prior b/tsDMARD. |
|
E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK), pharmacodynamics, and immunogenicity of ABBV 154. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA. 2. Participant has ≥ 6 swollen joints (based on 66 joint count) and ≥ 6 tender joints (based on 68 joint count) at baseline. 3. Subject must have had inadequate response to at least one of the following prior b/tsDMARD treatments for RA (or corresponding biosimilar): - Tumor necrosis factor inhibitors: adalimumab, certolizumab pegol, etanercept, golimumab, infliximab - Interleukin-1 receptor inhibitors: anakinra - Interleukin-6 receptor inhibitors: tocilizumab, sarilumab - CD20-directed cytolytic antibodies: rituximab - T cell costimulation modulators: abatacept - Janus Kinase inhibitors: baricitinib, filgotinib, peficitinib, tofacitinib, upadacitinib - Investigational drug with positive efficacy data available from confirmatory trials, as agreed with the AbbVie TA MD 4. Participants must be on stable dose of methotrexate (MTX).
|
|
E.4 | Principal exclusion criteria |
1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of 50% improvement as measured by American College of Rheumatology response criteria (ACR50) at Week 12. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Change in Disease Activity Score (DAS) 28 (CRP) from Baseline; 2. Change in Clinical Disease Activity Index (CDAI) from Baseline; 3. Achievement of ACR20; 4. Achievement of ACR70; 5. Achievement of Low Disease Activity (LDA) defined by DAS28 (CRP) ≤ 3.2; 6. Achievement of LDA defined by CDAI ≤ 10; 7. Achievement of clinical remission defined by DAS28 (CRP) < 2.6; 8. Achievement of clinical remission defined by CDAI ≤ 2.8; and 9. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) from Baseline |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Also assess Immunogenicity of ABBV-154 |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Israel |
Japan |
Korea, Republic of |
New Zealand |
Puerto Rico |
Taiwan |
United States |
Poland |
Netherlands |
Spain |
Czechia |
Germany |
Greece |
Italy |
Hungary |
Russian Federation |
Slovakia |
Turkey |
Ukraine |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end-of-study is defined as 70 days after the last study drug administration. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 15 |