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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823391
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE March 27, 2019
Actual Primary Completion Date April 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Change in disease activity score (DAS) 28 (C-reactive protein [CRP]) from Baseline (BL) for ABBV-3373 and adalimumab [ Time Frame: At Week 12 ]
DAS is a combined index used to measure the disease activity in patients with RA.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Change in clinical disease activity index (CDAI) from BL for ABBV-3373 and adalimumab [ 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 for ABBV-3373 and adalimumab [ 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 for ABBV-3373 and adalimumab [ 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) for ABBV-3373 and adalimumab [ 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 for ABBV-3373 and adalimumab [ 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis (RA)
Intervention  ICMJE
  • Drug: ABBV-3373
    ABBV-3373 is administered as intravenous (IV) injection
  • 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
  • Drug: Placebo for adalimumab
    Placebo for adalimumab is administered as subcutaneous (SC) injection
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: ABBV-3373
    • Drug: Placebo for adalimumab
  • 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.
    Interventions:
    • Drug: Placebo for ABBV-3373
    • Drug: Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2020)
48
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
45
Actual Study Completion Date  ICMJE August 26, 2020
Actual Primary Completion Date April 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   Israel,   Netherlands,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03823391
Other Study ID Numbers  ICMJE M16-560
2018-003053-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP