Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
A Phase 2b, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function. Synovial fibroblasts play a key role in RA pathogenesis, with treatment-refractory patients demonstrating increased numbers of these cells. The goal of this study is to evaluate the safety and effectiveness of ABBV-2294 (a combination of ABBV-722 and upadacitinib) compared to each drug alone in treating moderately to severely active RA. The platform study will measure improvements in disease activity using the American College of Rheumatology (ACR) criteria, changes in disease activity scores, and quality of life measures.
ABBV-2294 is an investigational combination drug being developed for the treatment of moderately to severely active rheumatoid arthritis. This is a Phase 2b, randomized, double-blind platform study. In sub-study 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment consisting of either ABBV-722 alone, upadacitinib alone, or various doses of ABBV-722 combined with upadacitinib. Adult participants with a diagnosis of moderately to severely active rheumatoid arthritis who have failed at least 1 prior biologic disease-modifying antirheumatic drug (bDMARD) will be enrolled. Around 250 participants will be enrolled in the study at multiple sites worldwide.
Participants will receive oral tablet doses of ABBV-2294 (combination of ABBV-722 and upadacitinib), ABBV-722 alone, or upadacitinib alone. The study comprises a 24-week Double-Blind Phase (Period 1) followed by an optional 52-week Blinded Long Term Extension Phase (Period 2), for a total treatment duration of up to 76 weeks. After completing treatment, participants will have a 30-day Follow-Up Period.
Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits through Week 76, followed by a follow-up visit. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: ABBVIE CALL CENTER
- Numero di telefono: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Documented clinical diagnosis of RA for >= 3 months and fulfills 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for Rheumatoid arthritis
- No clinically significant medical conditions that would interfere with study participation or compromise participant safety
- Willing and able to comply with procedures required in this Master Protocol and all actively enrolling substudies
- Female participants who are not pregnant or breastfeeding, with negative pregnancy tests at Screening and Baseline
Exclusion Criteria:
- Development of a major cardiovascular event (e.g., acute myocardial infarction, stroke) while on study treatment
- Serious infection (e.g., sepsis) which cannot be adequately controlled by anti-infective treatment
- Confirmed diagnosis of deep vein thrombosis, pulmonary embolus or arterial thrombosis
- Development of active tuberculosis at any time during the study
- Development of any malignancy except localized non-melanoma skin cancer or carcinoma in situ of the cervix
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: ABBV-2294 Dose A
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
Sperimentale: ABBV-2294 Dose B
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
Sperimentale: ABBV-2294 Dose C
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
Sperimentale: ABBV-722 Monotherapy
Participants will receive ABBV-722. At Week 12, participants will then be blindly switched to co-administration of ABBV-722 and upadacitinib. |
Oral Tablet |
|
Comparatore attivo: Upadacitinib Monotherapy
Participants will receive upadacitinib. |
Oral Tablet |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Achieving ACR50 Response
Lasso di tempo: Week 12
|
The ACR50 response is defined as at least 50% improvement in the American College of Rheumatology (ACR) criteria for rheumatoid arthritis. The ACR50 response requires at least 50% improvement in tender and swollen joint counts and at least 50% improvement in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function (HAQ-DI), and acute phase reactant (CRP or ESR). |
Week 12
|
|
Number of Participants Experiencing Adverse Events
Lasso di tempo: Up to 80 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 80 Weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Achieving ACR20 Response
Lasso di tempo: Week 12
|
ACR20 response is defined as at least 20% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate). |
Week 12
|
|
Percentage of Participants Achieving ACR70 Response
Lasso di tempo: Week 12
|
ACR70 response is defined as at least 70% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate). |
Week 12
|
|
Percentage of Participants Achieving Low Disease Activity Based on DAS28 (CRP) <= 3.2
Lasso di tempo: Week 12
|
Low Disease Activity (LDA) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) of <= 3.2. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) < 2.6
Lasso di tempo: Week 12
|
Clinical Remission (CR) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) of < 2.6. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants with a Change From Baseline in DAS28 (CRP)
Lasso di tempo: Baseline to Week 12
|
Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. A negative change from Baseline indicates improvement. |
Baseline to Week 12
|
|
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) <= 10
Lasso di tempo: Week 12
|
Low Disease Activity (LDA) is defined as a Clinical Disease Activity Index (CDAI) of <= 10. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants Achieving Clinical Remission Based on CDAI <= 2.8
Lasso di tempo: Week 12
|
Clinical Remission (CR) is defined as a Clinical Disease Activity Index (CDAI) of <= 2.8. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity. |
Week 12
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: ABBVIE INC., AbbVie
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M26-032
- 2026-526301-15-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Periodo di condivisione IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criteri di accesso alla condivisione IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .