Back to resultsA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis (RA)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-3373
Placebo for ABBV-3373
Adalimumab
Placebo for adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid Arthritis (RA), ABBV-3373, Adalimumab
Eligibility 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 methotrexate. 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.
Sites / Locations
- Rheum Assoc of North Alabama /ID# 213626
- AZ Arthritis and Rheum Researc /ID# 208515
- C.V. Mehta MD, Med Corporation /ID# 213068
- Robin K. Dore MD, Inc /ID# 213045
- Inland Rheum & Osteo Med Grp /ID# 213044
- Suncoast Clinical Research /ID# 213973
- Arthritis Center, Inc. /ID# 213972
- W. Broward Rheum Assoc Inc. /ID# 211017
- BayCare Medical Group, Inc. /ID# 213935
- Institute of Arthritis Researc /ID# 213043
- PRN Professional Research Network of Kansas, LLC /ID# 213046
- Clinvest Research LLC /ID# 215451
- Duke Early Phase Research Unit (DCRI) /ID# 213212
- Paramount Medical Research Con /ID# 209042
- STAT Research, Inc. /ID# 213933
- West Tennessee Research Inst /ID# 208838
- PCCR Solution /ID# 215457
- Trinity Universal Research Association /ID# 209167
- Charite Research Organisation GmbH /ID# 210216
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
- DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
- Budai Irgalmasrendi Korhaz /ID# 208877
- Debreceni Egyetem Klinikai Kozpont /ID# 210164
- Rambam Health Care Campus /ID# 212747
- Sheba Medical Center /ID# 211339
- Academisch Medical center Amsterdam /ID# 209303
- SANUS Szpital Specjalistyczny /ID# 209022
- Reumatika - Centrum Reumatologii NZOZ /ID# 209220
- GCM Medical Group, PSC /ID# 208154
- Mindful Medical Research /ID# 208403
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ABBV-3373 Followed by Placebo
Adalimumab
Arm Description
Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.
Outcomes
Primary Outcome Measures
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Secondary Outcome Measures
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Change From Baseline in Simplified Disease Activity Index (SDAI)
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03823391
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Detailed Description
This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period.
In the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.
At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis (RA), ABBV-3373, Adalimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABBV-3373 Followed by Placebo
Arm Type
Experimental
Arm Description
Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.
Intervention Type
Drug
Intervention Name(s)
ABBV-3373
Intervention Description
ABBV-3373 is administered as intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo for ABBV-3373
Intervention Description
Placebo for ABBV-3373 is administered as IV infusion
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab is administered as subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo for adalimumab
Intervention Description
Placebo for adalimumab is administered as subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
Description
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
Description
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Simplified Disease Activity Index (SDAI)
Description
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
Description
The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
Description
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 methotrexate. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rheum Assoc of North Alabama /ID# 213626
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 208515
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
C.V. Mehta MD, Med Corporation /ID# 213068
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Robin K. Dore MD, Inc /ID# 213045
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheum & Osteo Med Grp /ID# 213044
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Suncoast Clinical Research /ID# 213973
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 213972
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
W. Broward Rheum Assoc Inc. /ID# 211017
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 213935
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
Institute of Arthritis Researc /ID# 213043
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 213046
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Clinvest Research LLC /ID# 215451
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810-2607
Country
United States
Facility Name
Duke Early Phase Research Unit (DCRI) /ID# 213212
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Paramount Medical Research Con /ID# 209042
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
STAT Research, Inc. /ID# 213933
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
West Tennessee Research Inst /ID# 208838
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
PCCR Solution /ID# 215457
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Trinity Universal Research Association /ID# 209167
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Facility Name
Charite Research Organisation GmbH /ID# 210216
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
City
Balatonfüred
State/Province
Veszprem
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz /ID# 208877
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 210164
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Rambam Health Care Campus /ID# 212747
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sheba Medical Center /ID# 211339
City
Ramat Gan
ZIP/Postal Code
5239424
Country
Israel
Facility Name
Academisch Medical center Amsterdam /ID# 209303
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
SANUS Szpital Specjalistyczny /ID# 209022
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Reumatika - Centrum Reumatologii NZOZ /ID# 209220
City
Warsaw
ZIP/Postal Code
02-691
Country
Poland
Facility Name
GCM Medical Group, PSC /ID# 208154
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 208403
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
http://www.rxabbvie.com
Description
Related Info
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
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