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A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Primary Purpose

Rheumatoid Arthritis (RA)

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Elsubrutinib

Upadacitinib

Placebo for elsubrutinib

Placebo for upadacitinib

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Elsubrutinib, ABBV-105, Upadacitinib, ABBV-599, Rheumatoid Arthritis (RA), Long-term extension (LTE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant has completed Study M16-063
Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol
Participant is willing and/or able to comply with procedures required in the current study protocol

Exclusion Criteria:

Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063)
Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug

Sites / Locations

Cliniques Universitaires Saint Luc /ID# 207719
UZ Leuven /ID# 207722
Rheumatology Research Assoc /ID# 207769
Manitoba Clinic /ID# 206852
CIADS Research Co Ltd /ID# 206853
Mount Sinai Hosp.-Toronto /ID# 206851
Dr. Latha Naik /ID# 213440
Revmatolog s.r.o. /ID# 209941
Revmatologicky ustav Praha /ID# 209943
Revmatologie MUDr. Klara Sirova /ID# 209944
CCR Czech a.s /ID# 209942
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186
Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184
Revita Reumatologiai Rendelo /ID# 208187
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185
Malopolskie Centrum Kliniczne /ID# 209902
McBk Sc /Id# 212577
NBR Polska /ID# 209904
ClinicMed Daniluk, Nowak Sp.j. /ID# 212578
Reumatika - Centrum Reumatologii NZOZ /ID# 209903
Hospital Universitario A Coruña - CHUAC /ID# 207732
Hospital Unversitario Marques de Valdecilla /ID# 207729
Hospital Regional de Malaga /ID# 207735
Hospital Clinic /ID# 207740
Hospital Universitario Basurto /ID# 207737
Hospital Universitario Virgen de las Nieves /ID# 209975
Hospital Clinico Universitario San Carlos /ID# 207738
Hospital Universitario y Politecnico La Fe /ID# 207739
University of Oxford /ID# 210571

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

ABBV-599 in M16-063/ABBV-599 in M16-763

ABBV-105 60 mg/UPA placebo

ABBV-105 20 mg/UPA placebo

ABBV-105 5 mg/UPA placebo

UPA 15 mg/ABBV-105 placebo

Placebo in M16-063/ABBV-599 in M16-763

Arm Description

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks

Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

An adverse event (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. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Secondary Outcome Measures

Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763

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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP 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 Disease Activity Score 28 C-reactive Protein (DAS28-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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.

Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.

Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063

The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria

The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10.

Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria

The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a total CDAI score of less than or equal to 2.8.

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria: ≥ 20% improvement in 68-tender joint count from Baseline of Study M16-063 ≥ 20% improvement in 66-swollen joint count from Baseline of Study M16-063 and ≥ 20% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: 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) High-sensitivity C-reactive protein (hsCRP)

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria: ≥ 50% improvement in 68-tender joint count from Baseline of Study M16-063 ≥ 50% improvement in 66-swollen joint count from Baseline of Study M16-063 and ≥ 50% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: 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) High-sensitivity C-reactive protein (hsCRP)

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria: ≥ 70% improvement in 68-tender joint count from Baseline of Study M16-063 ≥ 70% improvement in 66-swollen joint count from Baseline of Study M16-063 and ≥ 70% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: 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) High-sensitivity C-reactive protein (hsCRP)

Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063

Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.

Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063

Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.

Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063

Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.

Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063

Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.

Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063

The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.

Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from baseline in the overall score indicates improvement.

Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063

C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline indicates improvement.

Change in Morning Stiffness Severity From Baseline of Study M16-063

Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.

Full Information

NCT ID

NCT03823378

First Posted

January 8, 2019

Last Updated

August 18, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03823378

Brief Title

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Official Title

A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

September 9, 2020 (Actual)

Study Completion Date

September 9, 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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).

Detailed Description

This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib [ELS] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis (RA)

Keywords

Elsubrutinib, ABBV-105, Upadacitinib, ABBV-599, Rheumatoid Arthritis (RA), Long-term extension (LTE)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABBV-599 in M16-063/ABBV-599 in M16-763

Arm Type

Experimental

Arm Description

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks

Arm Title

ABBV-105 60 mg/UPA placebo

Arm Type

Experimental

Arm Description

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Arm Title

ABBV-105 20 mg/UPA placebo

Arm Type

Experimental

Arm Description

20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Arm Title

ABBV-105 5 mg/UPA placebo

Arm Type

Experimental

Arm Description

5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Arm Title

UPA 15 mg/ABBV-105 placebo

Arm Type

Experimental

Arm Description

15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks

Arm Title

Placebo in M16-063/ABBV-599 in M16-763

Arm Type

Experimental

Arm Description

Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763

Intervention Type

Drug

Intervention Name(s)

Elsubrutinib

Other Intervention Name(s)

ABBV-105

Intervention Description

Elsubrutinib capsule will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

ABT-494

Intervention Description

Upadacitinib tablet will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo for elsubrutinib

Intervention Description

Placebo capsule for elsubrutinib will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo for upadacitinib

Intervention Description

Upadacitinib placebo tablet will be administered orally.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks

Secondary Outcome Measure Information:

Title

Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.

Time Frame

Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-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 (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.

Time Frame

Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria

Description

The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10.

Time Frame

Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria

Description

The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a total CDAI score of less than or equal to 2.8.

Time Frame

Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063

Description

C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline indicates improvement.

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

Title

Change in Morning Stiffness Severity From Baseline of Study M16-063

Description

Time Frame

Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant has completed Study M16-063 Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol Participant is willing and/or able to comply with procedures required in the current study protocol Exclusion Criteria: Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063) Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Cliniques Universitaires Saint Luc /ID# 207719

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Leuven /ID# 207722

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Rheumatology Research Assoc /ID# 207769

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

Manitoba Clinic /ID# 206852

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

CIADS Research Co Ltd /ID# 206853

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3N 0K6

Country

Canada

Facility Name

Mount Sinai Hosp.-Toronto /ID# 206851

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

Dr. Latha Naik /ID# 213440

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 3H3

Country

Canada

Facility Name

Revmatolog s.r.o. /ID# 209941

City

Jihlava 1

State/Province

Jihlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Revmatologicky ustav Praha /ID# 209943

City

Prague 2

State/Province

Praha 2

ZIP/Postal Code

128 00

Country

Czechia

Facility Name

Revmatologie MUDr. Klara Sirova /ID# 209944

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

CCR Czech a.s /ID# 209942

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184

City

Nyíregyháza

State/Province

Szabolcs-Szatmar-Bereg

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Revita Reumatologiai Rendelo /ID# 208187

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Malopolskie Centrum Kliniczne /ID# 209902

City

Cracow

State/Province

Malopolskie

ZIP/Postal Code

30-149

Country

Poland

Facility Name

McBk Sc /Id# 212577

City

Grodzisk Mazowiecki

State/Province

Mazowieckie

ZIP/Postal Code

05-825

Country

Poland

Facility Name

NBR Polska /ID# 209904

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

00-465

Country

Poland

Facility Name

ClinicMed Daniluk, Nowak Sp.j. /ID# 212578

City

Białystok

State/Province

Podlaskie

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Reumatika - Centrum Reumatologii NZOZ /ID# 209903

City

Warsaw

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Hospital Universitario A Coruña - CHUAC /ID# 207732

City

A Coruña

State/Province

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Unversitario Marques de Valdecilla /ID# 207729

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Regional de Malaga /ID# 207735

City

Málaga

State/Province

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Clinic /ID# 207740

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Basurto /ID# 207737

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital Universitario Virgen de las Nieves /ID# 209975

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Hospital Clinico Universitario San Carlos /ID# 207738

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario y Politecnico La Fe /ID# 207739

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

University of Oxford /ID# 210571

City

Oxford

ZIP/Postal Code

OX3 7LF

Country

United Kingdom

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

https://www.rxabbvie.com/

Description

Related Info.

Learn more about this trial

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

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