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A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active 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: NCT03682705
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a phase 2 study to evaluate safety and efficacy of ABBV-105 and ABBV-599 (ABBV-105 plus upadacitinib) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs(bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: Upadacitinib Drug: ABBV-105 Drug: Upadacitinib placebo Drug: ABBV-105 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : March 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 6
Participants receiving upadacitinib placebo and ABBV-105 placebo
Drug: Upadacitinib placebo
Upadacitinib placebo tablet will be administered orally.

Drug: ABBV-105 placebo
ABBV-105 placebo capsule will be administered orally.

Experimental: Group 5
Participants receiving upadacitinib and ABBV-105 placebo
Drug: Upadacitinib
Upadacitinib tablet will be administered orally.
Other Name: ABT-494

Drug: ABBV-105 placebo
ABBV-105 placebo capsule will be administered orally.

Experimental: Group 4
Participants receiving upadacitinib placebo and ABBV-105 dose C
Drug: ABBV-105
ABBV-105 capsule will be administered orally.

Drug: Upadacitinib placebo
Upadacitinib placebo tablet will be administered orally.

Experimental: Group 3
Participants receiving upadacitinib placebo and ABBV-105 dose B
Drug: ABBV-105
ABBV-105 capsule will be administered orally.

Drug: Upadacitinib placebo
Upadacitinib placebo tablet will be administered orally.

Experimental: Group 2
Participants receiving upadacitinib placebo and ABBV-105 dose A
Drug: ABBV-105
ABBV-105 capsule will be administered orally.

Drug: Upadacitinib placebo
Upadacitinib placebo tablet will be administered orally.

Experimental: Group 1
Participants receiving upadacitinib and ABBV-105 dose A
Drug: Upadacitinib
Upadacitinib tablet will be administered orally.
Other Name: ABT-494

Drug: ABBV-105
ABBV-105 capsule will be administered orally.




Primary Outcome Measures :
  1. Change from Baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) [ Time Frame: At Week 12 ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.


Secondary Outcome Measures :
  1. Change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Up to Week 12 ]
    The CDAI is validated measure of RA disease activity.

  2. Proportion of participants achieving Clinical Remission (CR) [ Time Frame: At Week 12 ]
    Clinical Remission is defined as DAS28 CRP <2.6

  3. Proportion of participants achieving Low Disease Activity (LDA) [ Time Frame: At Week 12 ]
    LDA is defined as DAS28 CRP<=3.2

  4. American College of Rheumatology (ACR)20 response rate [ Time Frame: Up to Week 12 ]
    ACR 20 response rate will be determined based on 20%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).

  5. Change from baseline in individual components of ACR response [ Time Frame: Up to Week 12 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

  6. Change from baseline in DAS28(CRP) [ Time Frame: Up to Week 12 ]
    The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.

  7. Change from baseline in morning stiffness [ Time Frame: Up to Week 12 ]
    Duration of morning stiffness on numeric rating scale (from 0 to 10) will be assessed.

  8. Change from baseline in HAQ-DI [ Time Frame: Up to Week 12 ]
    The HAQ DI is a patient-reported questionnaire. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.

  9. Proportion of participants achieving Minimal Clinically Important Difference (MCID) in change from baseline in HAQ-DI [ Time Frame: Up to Week 12 ]
    It is defined as change from baseline in HAQ-DI ≤ -0.3

  10. Proportion of participants achieving European League Against Rheumatism (EULAR) Boolean remission [ Time Frame: Up to Week 12 ]
    A EULAR remission reflects improvement in disease activity and attainment of a lower degree of disease activity.

  11. Change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Up to Week 12 ]
    SDAI is validated measure of RA disease activity.

  12. ACR 50 response rate [ Time Frame: Up to 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).

  13. ACR 70 response rate [ Time Frame: Up to Week 12 ]
    ACR 70 response rate will be determined based on 70% 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).

  14. Change from baseline in DAS28 (Erythrocyte Sedimentation Rate (ESR)) [ Time Frame: Up to Week 12 ]
    The change in the Disease Activity Score (DAS)28 (erythrocyte sedimentation rate) from the baseline is assessed.

  15. Proportion of participants achieving ACR remission [ Time Frame: Up to Week 12 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA for >=3 months based on the 2010 ACR/EULAR classification criteria for RA.
  • Participant meets the following minimum disease activity criteria:
  • >=6 swollen joints (based on 66 joint counts) and >=6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
  • hsCRP >=3 mg/L (central lab) at Screening Visit.
  • Participants must have been treated for >=3 months with >=1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.
  • Participants must have been receiving csDMARD therapy >=3 months and on a stable dose for >=4 weeks prior to the first dose of study drug.
  • Participants must have discontinued all bDMARDs prior to the first dose of study drug.

Exclusion Criteria:

  • Participant have prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of >= 30 days is required for any JAK inhibitor prior to the first dose of study drug.

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): NCT03682705


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03682705    
Other Study ID Numbers: M16-063
2018-000666-10 ( EudraCT Number )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 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

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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.: No
Keywords provided by AbbVie:
ABBV-105
Upadacitinib
ABBV-599
Rheumatoid Arthritis
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
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents