A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis
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| ClinicalTrials.gov Identifier: NCT03823391 |
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Recruitment Status :
Completed
First Posted : January 30, 2019
Last Update Posted : September 25, 2020
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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Brief Summary:
This is a adalimumab active-controlled study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity and efficacy following multiple intravenous (IV) injections of ABBV-3373 or multiple subcutaneous (SC) injections of adalimumab in participants with Rheumatoid Arthritis (RA) on background methotrexate (MTX). This study will also compare adalimumab with a synthetic control arm using historical placebo participants from similar trials to establish assay sensitivity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis (RA) | Drug: ABBV-3373 Drug: Placebo for ABBV-3373 Drug: Adalimumab Drug: Placebo for adalimumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis |
| Actual Study Start Date : | March 27, 2019 |
| Actual Primary Completion Date : | April 8, 2020 |
| Actual Study Completion Date : | August 26, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
Drug Information available for:
Adalimumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: ABBV-3373 Followed by Placebo
Participants will be administered with ABBV-3373 and placebo for adalimumab every other week for 12 weeks. After 12 weeks, participants will receive placebo for adalimumab every other week until Week 22.
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Drug: ABBV-3373
ABBV-3373 is administered as intravenous (IV) injection Drug: Placebo for adalimumab Placebo for adalimumab is administered as subcutaneous (SC) injection |
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Experimental: Adalimumab
Participants will be administered with placebo for ABBV-3373 and adalimumab every other week for 12 weeks. After 12 weeks, participants will receive adalimumab every other week until Week 22.
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Drug: Placebo for ABBV-3373
Placebo for ABBV-3373 is administered as intravenous (IV) injection Drug: Adalimumab Adalimumab is administered as subcutaneous (SC) injection
Other Name: Humira |
Primary Outcome Measures :
- Change in disease activity score (DAS) 28 (C-reactive protein [CRP]) from Baseline (BL) [ Time Frame: At Week 12 ]DAS is a combined index used to measure the disease activity in patients with RA.
Secondary Outcome Measures :
- Change in clinical disease activity index (CDAI) from BL [ Time Frame: At Week 12 ]The CDAI is a composite index for assessing disease activity based on the swollen/tender joint count along with patient and physician global assessment.
- Change in simplified disease activity index (SDAI) from BL [ Time Frame: At Week 12 ]The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count, patient and physician global assessment of disease activity and level of C-reactive Protein (CRP).
- Change in DAS (28 joints) (DAS28) erythrocyte sedimentation rate (ESR) from BL [ Time Frame: At Week 12 ]The DAS is a combined index used to measure the disease activity in patients with RA.
- Percentage of participants achieving a low disease activity (LDA) [ Time Frame: At Week 12 ]Low disease activity is defined as DAS28 (CRP) <= 3.2
- Percentage of participants achieving American College of Rheumatology (ACR) 50 [ Time Frame: At Week 12 ]ACR 50 response rate will be determined based on 50% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and ≥ 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale (VAS)), Patient's Global Assessment of Disease Activity (PtGA), Physician's Global Assessment of Disease Activity (PhGA), Health Assessment Questionnaire Disability Index (HAQ-DI), or high-sensitivity C-reactive protein (hsCRP).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
- Participant meets the following disease activity criteria: >= 4 swollen joints (based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) >= 3.2 at Screening.
- Participant has an incomplete response to MTX. Participants must have been on oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Exclusion Criteria:
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823391
Locations
Show 30 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03823391 |
| Other Study ID Numbers: |
M16-560 2018-003053-21 ( EudraCT Number ) |
| First Posted: | January 30, 2019 Key Record Dates |
| Last Update Posted: | September 25, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
| URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by AbbVie:
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Rheumatoid Arthritis (RA) ABBV-3373 Adalimumab |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |