A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate (SELECT-EARLY)

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ClinicalTrials.gov Identifier: NCT02706873

Recruitment Status : Completed

First Posted : March 11, 2016

Results First Posted : October 4, 2019

Last Update Posted : December 5, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AbbVie

Study Description

Brief Summary:

The objectives of Period 1 were the following:

To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA;
To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA.

The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Placebo to Upadacitinib Drug: Methotrexate Drug: Placebo to Methotrexate Drug: Upadacitinib	Phase 3

Detailed Description:

This study includes 2 periods (a 48-week double-blind treatment period and a long-term extension period) and a Japan substudy. In Period 1 participants will be randomized in a 1:1:1 ratio to treatment Groups 2, 3, and 4 below, except for participants from Japan, who will be randomized in a 2:1:1:1 ratio to Groups 1, 2, 3, and 4:

Group 1: Upadacitinib 7.5 mg once daily (QD) monotherapy (participants in Japan only)
Group 2: Upadacitinib 15 mg QD monotherapy
Group 3: Upadacitinib 30 mg QD monotherapy
Group 4: Methotrexate monotherapy

Participants who complete the Week 48 visit (end of Period 1) will enter the long-term extension, Period 2 (212 weeks) and continue study treatment per assignment at the end of Period 1 in a blinded fashion. Starting with Protocol Amendment 6, participants receiving upadacitinib 15 mg and 30 mg QD will receive open-label upadacitinib 15 mg QD, and participants receiving methotrexate will receive open-label methotrexate.

A global analysis will be conducted for the comparisons of the primary and secondary efficacy endpoints between the upadacitinib 15 mg QD and 30 mg QD treatment groups versus the methotrexate treatment group for all participants (excluding the Japan specific upadacitinib 7.5 mg treatment group). Analyses will be conducted separately for United States (US)/Food and Drug Administration (FDA), European Union (EU)/European Medicines Agency (EMA), and Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes, each according to a pre-specified sequence of primary and ranked secondary endpoints.

A separate Japan sub-study analysis will be conducted for the comparisons of the efficacy endpoints between the upadacitinib 7.5 mg QD, 15 mg QD, and 30 mg QD treatment groups versus the methotrexate treatment group for participants enrolled in Japan only.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1002 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Participants were to be randomized in a 1:1:1 ratio to treatment Groups 2, 3, and 4 below, except for participants from Japan, who were to be randomized in a 2:1:1:1 ratio to Groups 1, 2, 3, and 4: Group 1: Upadacitinib 7.5 mg QD monotherapy (Japan only) Group 2: Upadacitinib 15 mg QD monotherapy (43 countries, including Japan) Group 3: Upadacitinib 30 mg QD monotherapy (43 countries, including Japan) Group 4: MTX monotherapy (43 countries, including Japan)
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date :	February 23, 2016
Actual Primary Completion Date :	March 15, 2018
Actual Study Completion Date :	November 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Upadacitinib

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Methotrexate Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks. Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.	Drug: Placebo to Upadacitinib Tablet; Oral Drug: Methotrexate Capsule or Tablet; Oral
Experimental: Upadacitinib 7.5 mg (Japan-only) Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.	Drug: Placebo to Methotrexate Capsule or Tablet; Oral Drug: Upadacitinib Tablet; Oral Other Names: ABT-494 Rinvoq
Experimental: Upadacitinib 15 mg Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.	Drug: Placebo to Methotrexate Capsule or Tablet; Oral Drug: Upadacitinib Tablet; Oral Other Names: ABT-494 Rinvoq
Experimental: Upadacitinib 30 mg Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.	Drug: Placebo to Methotrexate Capsule or Tablet; Oral Drug: Upadacitinib Tablet; Oral Other Names: ABT-494 Rinvoq

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis [ Time Frame: Baseline and Week 12 ]
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. ≥ 50% improvement in 68-tender joint count;
2. ≥ 50% improvement in 66-swollen joint count; and
3. ≥ 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).
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis [ Time Frame: Week 24 ]
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 24.

The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

A DAS28 score less than 2.6 indicates clinical remission.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis [ Time Frame: Baseline and Week 12 ]
The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. ≥ 20% improvement in 68-tender joint count;
2. ≥ 20% improvement in 66-swollen joint count; and
3. ≥ 20% 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).
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis [ Time Frame: Baseline to Week 24 ]
The 2nd primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24.

The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.

Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.

Secondary Outcome Measures :

Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis [ Time Frame: Baseline to Week 12 ]
The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis [ Time Frame: Baseline to week 12 ]
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.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis [ Time Frame: 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 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.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis [ Time Frame: Baseline to week 12 ]
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis [ Time Frame: Baseline to Week 24 ]
The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis [ Time Frame: Baseline to Week 24 ]
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.
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis [ Time Frame: Baseline and Week 24 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. ≥ 50% improvement in 68-tender joint count;
2. ≥ 50% improvement in 66-swollen joint count; and
3. ≥ 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).
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis [ Time Frame: Week 24 ]
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 hsCRP (in mg/L). Scores on the DAS28 range from 0 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.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis [ Time Frame: Baseline to Week 24 ]
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis [ Time Frame: Week 24 ]
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score. Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis [ Time Frame: Baseline and Week 12 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. ≥ 70% improvement in 68-tender joint count;
2. ≥ 70% improvement in 66-swollen joint count; and
3. ≥ 70% 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).
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis [ Time Frame: Baseline and Week 24 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. ≥ 20% improvement in 68-tender joint count;
2. ≥ 20% improvement in 66-swollen joint count; and
3. ≥ 20% 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).
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis [ Time Frame: Baseline and Week 24 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. ≥ 70% improvement in 68-tender joint count;
2. ≥ 70% improvement in 66-swollen joint count; and
3. ≥ 70% 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).
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study [ Time Frame: Baseline and Week 12 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. ≥ 20% improvement in 68-tender joint count;
2. ≥ 20% improvement in 66-swollen joint count; and
3. ≥ 20% 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).
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study [ Time Frame: Baseline and Week 12 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. ≥ 50% improvement in 68-tender joint count;
2. ≥ 50% improvement in 66-swollen joint count; and
3. ≥ 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).
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study [ Time Frame: Baseline and Week 12 ]
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. ≥ 70% improvement in 68-tender joint count;
2. ≥ 70% improvement in 66-swollen joint count; and
3. ≥ 70% 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).
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study [ Time Frame: Baseline to Week 12 ]
The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study [ Time Frame: Baseline to week 12 ]
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 From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study [ Time Frame: Baseline to Week 12 ]
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study [ Time Frame: 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 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 Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study [ Time Frame: Week 24 ]
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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

A DAS28 score less than 2.6 indicates clinical remission.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study [ Time Frame: Baseline to Week 24 ]
The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.

Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study [ Time Frame: Week 24 ]
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score. Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).

Eligibility Criteria

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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:

Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
Participants with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
Participant meets both of 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.
high sensitivity C reactive protein (hsCRP) ≥ 5 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L at Screening Visit.
Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor (RF) and positive anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose ≥ 1 week prior to the first dose of study drug.

Exclusion Criteria:

Intolerant to Methotrexate (MTX).
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.

Contacts and Locations

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): NCT02706873

Locations

Show 290 study locations

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United States, California
TriWest Research Associates- La Mesa /ID# 143738
La Mesa, California, United States, 91942
Desert Medical Advances /ID# 143730
Palm Desert, California, United States, 92260
United States, Florida
International Medical Research - Daytona /ID# 143748
Daytona Beach, Florida, United States, 32117
FL Med Ctr and Research, Inc. /ID# 143724
Miami, Florida, United States, 33142
Millennium Research /ID# 143736
Ormond Beach, Florida, United States, 32174
Arthritis Research of Florida /ID# 143743
Palm Harbor, Florida, United States, 34684-2672
Sarasota Arthritis Center /ID# 145978
Sarasota, Florida, United States, 34239
FL Med Clinic, PA /ID# 143744
Zephyrhills, Florida, United States, 33542
United States, Illinois
Deerbrook Medical Associates /ID# 143728
Vernon Hills, Illinois, United States, 60061
United States, Kentucky
Four Rivers Clinical Research /ID# 143741
Paducah, Kentucky, United States, 42003
United States, New Jersey
Ocean Rheumatology, PA /ID# 143737
Toms River, New Jersey, United States, 08755
Arthritis Rheumatic Back Disorder /ID# 143733
Voorhees, New Jersey, United States, 08043
United States, North Dakota
Trinity Health Med Arts Clinic /ID# 143727
Minot, North Dakota, United States, 58701
United States, Ohio
STAT Research, Inc. /ID# 143750
Vandalia, Ohio, United States, 45377-9464
United States, Oklahoma
Healthcare Research Consultant /ID# 143747
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Advanced Rheumatology & Arthri /ID# 147947
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653
Summerville, South Carolina, United States, 29486-7887
United States, Tennessee
West Tennessee Research Inst /ID# 143723
Jackson, Tennessee, United States, 38305
Dr. Ramesh Gupta /ID# 143732
Memphis, Tennessee, United States, 38119
United States, Texas
Diagnostic Group Integrated He /ID# 152921
Beaumont, Texas, United States, 77701
Adriana Pop-Moody MD Clinic PA /ID# 147626
Corpus Christi, Texas, United States, 78404
Doctor's Hosp at Renaissance /ID# 156407
Edinburg, Texas, United States, 78539
MedResearch Inc. /ID# 156409
El Paso, Texas, United States, 79935
Rheumatic Disease Clin Res Ctr /ID# 151103
Houston, Texas, United States, 77004
Accurate Clinical Research /ID# 143749
Houston, Texas, United States, 77089
SW Rheumatology Res. LLC /ID# 143745
Mesquite, Texas, United States, 75150
Sun Research Institute /ID# 159546
San Antonio, Texas, United States, 78215
Accurate Clinical Management /ID# 159543
San Antonio, Texas, United States, 78229
NextGen Clinical Trials LLP /ID# 150930
San Antonio, Texas, United States, 78229
Arthritis Clinic of Central TX /ID# 159541
San Marcos, Texas, United States, 78666
Arthritis & Osteoporosis Clinic /ID# 159542
Waco, Texas, United States, 76710
United States, Virginia
Arthritis Clinic of N. VA, P.C /ID# 143734
Arlington, Virginia, United States, 22205
Argentina
Aprillus Asistencia e Investig /ID# 149179
Capital Federal, Buenos Aires, Argentina, 1046
Iari /Id# 148595
San isidro, Buenos Aires, Argentina, 1646
Instituto CAICI /ID# 143141
Rosario, Santa FE, Argentina, 2000
Org Medica de Investigacion /ID# 143142
Buenos Aires, Argentina, C1015ABO
Consultora Integral de Salud S /ID# 143144
Cordoba, Argentina, 5900
Centro Integral de Reumatologi /ID# 143143
San Miguel de Tucuman, Argentina, 4000
Centro Medico Privado/Reuma /ID# 143140
San Miguel de Tucuman, Argentina, 4000
Australia, New South Wales
Royal Prince Alfred Hospital /ID# 143149
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Rheumatology Research Unit /ID# 143147
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
The Queen Elizabeth Hospital /ID# 143148
Woodville, South Australia, Australia, 5011
Australia, Tasmania
Southern Clinical Research Pty /ID# 143150
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Emeritus Research /ID# 143146
Camberwell, Victoria, Australia, 3124
Belarus
First City Clinical Hospital /ID# 159020
Minsk, Belarus, 220013
City Clinical Hospital #9 /ID# 145650
Minsk, Belarus, 220116
Belgium
Rhumaconsult SPRL /ID# 143158
Charleroi, Hainaut, Belgium, 6000
Algemeen Stedelijk Ziekenhuis /ID# 153504
Aalst, Oost-Vlaanderen, Belgium, 9300
UZ Gent /ID# 143157
Gent, Oost-Vlaanderen, Belgium, 9000
ReumaClinic Genk /ID# 143159
Genk, Belgium, 3600
CHU Ambroise Pare /ID# 152955
Mons, Belgium, 7000
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 143161
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 143162
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
Clinical Center University of Sarajevo /ID# 143164
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
CIP - Centro Internacional de Pesquisa /ID# 143171
Goiânia, Goias, Brazil, 74110-120
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 143169
Curitiba, Parana, Brazil, 80030-110
Hospital de Clinicas de Porto Alegre /ID# 143168
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
LMK Sevicos Medicos S/S /ID# 143167
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 143166
São Paulo, Sao Paulo, Brazil, 04266-010
CCBR Brasil /ID# 150925
Rio de Janeiro, Brazil, 22271-100
Bulgaria
MHAT Trimontsium /ID# 143173
Plovdiv, Bulgaria, 4000
UMHAT Pulmed OOD /ID# 143176
Plovdiv, Bulgaria, 4000
MHAT Kaspela /ID# 143172
Plovdiv, Bulgaria, 4001
Diagnostic Consultative Center /ID# 143174
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski /ID# 143175
Sofia, Bulgaria, 1612
Canada, Alberta
Rheumatology Research Assoc /ID# 143206
Edmonton, Alberta, Canada, T5M 0H4
Canada, Manitoba
Manitoba Clinic /ID# 143203
Winnipeg, Manitoba, Canada, R3A IM3
Ciads /Id# 143205
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Ontario
CA Ctr for Clin Trials CCCT /ID# 159080
Thornhill, Ontario, Canada, L4J 1W3
Canada, Quebec
Ctr. de Rheum de l'est du QC /ID# 151317
Rimouski, Quebec, Canada, G5L 8W1
Chile
Ctr de Inv Clinica del Sur /ID# 143208
Temuco, Araucania, Chile, 4781156
Someal /Id# 143207
Providencia, Santiago, Chile, 7510186
Quantum Research LTDA. /ID# 143210
Puerto Varas, Chile, 5550170
Quantum Research Stgo. /ID# 145651
Santiago, Chile, 7500588
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 143209
Santiago, Chile, 7510047
Investigaciones Medicas SSMSO /ID# 151685
Santiago, Chile, 8207257
Centro de Estudios Clinicos Qu /ID# 152913
Vina Del Mar, Chile
China, Anhui
1st Aff Hosp of Bengbu Med Col /ID# 162974
Bengbu, Anhui, China, 233099
China, Fujian
The 1st Aff Hosp Xiamen Univ /ID# 162076
Xiamen, Fujian, China, 361003
China, Guangdong
1st Aff Hosp of Shantou Univ /ID# 162968
Shantou, Guangdong, China, 515041
Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 143214
Bogota, Cundinamarca, Colombia, 110221
Ctr Int de Reum del Caribe SAS /ID# 143211
Barranquilla, Colombia, 80002
Riesgo de Fractura S.A - CAYRE /ID# 143212
Bogota, Colombia, 110221
Simedics IPS SAS /ID# 152572
Bogota, Colombia, 110221
Fund Inst de Reum F. Chalem /ID# 159544
Bogotá, Colombia
Medicity S.A.S. /ID# 143213
Bucaramanga, Colombia, 680003
Croatia
Klinicki bolnicki centar Split /ID# 143216
Split, Croatia, 21000
Clinical Hospital Dubrava /ID# 143217
Zagreb, Croatia, 10000
Medical Center Kuna-Peric /ID# 143218
Zagreb, Croatia, 10000
Poliklinika Bonifarm /ID# 143215
Zagreb, Croatia, 10000
Czechia
L.K.N. Arthrocentrum, s.r.o /ID# 143224
Hlučín, Moravskoslezsky Kraj, Czechia, 748 01
CTCenter MaVe, s.r.o. /ID# 143226
Olomouc, Olomoucky Kraj, Czechia, 779 00
Nuselská poliklinika, Revmatologie /ID# 143232
Prague 4, Praha 4, Czechia, 140 00
Nuselská poliklinika, Revmatologie /ID# 143233
Prague 4, Praha 4, Czechia, 140 00
Thomayerova nemocnice /ID# 143228
Prague, Praha 4, Czechia, 140 59
PV MEDICAL Services s.r.o. /ID# 143234
Zlín 1, Zlin, Czechia, 760 01
RHEUMA s.r.o. /ID# 143230
Breclav, Czechia, 690 02
Revmatologie, s.r.o. /ID# 143223
Brno, Czechia, 638 00
Revmatologie Bruntal, s.r.o /ID# 143220
Bruntál, Czechia, 79201
Nemocnice Slany /ID# 143221
Slany, Czechia, 274 01
Medical Plus, s.r.o. /ID# 143219
Uherské Hradište, Czechia, 686 01
Estonia
Center of Clinical and Basic Research /ID# 143239
Tallinn, Harjumaa, Estonia, 10128
Paernu Hospital /ID# 143238
Pärnu, Estonia, 80010
East Tallinn Central Hospital /ID# 143240
Tallinn, Estonia, 10138
North Estonian Medical Centre /ID# 145456
Tallinn, Estonia, 13419
Germany
Rheumazentrum Ruhrgebiet /ID# 145652
Herne, Nordrhein-Westfalen, Germany, 44649
Uniklinik Koln /ID# 143248
Köln, Nordrhein-Westfalen, Germany, 50937
Praxis Walter, Rendsburg /ID# 143250
Rendsburg, Schleswig-Holstein, Germany, 24768
Rheumaforschungszentrum II /ID# 143247
Hamburg, Germany, 20095
Schoen Klinikum Hamburg Eilbek /ID# 143251
Hamburg, Germany, 22081
LMU Klinikum der Universität München /ID# 143249
Munich, Germany, 80337
Greece
University General Hospital Attikon /ID# 143252
Athens, Attiki, Greece, 12462
Guatemala
Clinicas Hospital Herrera Ller /ID# 153715
Ciudad de Guatemala, Guatemala, 01010
Creer /Id# 153713
Ciudad de Guatemala, Guatemala, 10010
Clin Especializada Med Interna /ID# 153716
Ciudad de Guatemala, Guatemala, 1011
Clinica Medica Reumatologia /ID# 153714
Ciudad de Guatemala, Guatemala, 1021
Clinica Medica Reumatologia /ID# 153931
Ciudad de Guatemala, Guatemala, 1021
Hong Kong
Queen Mary Hospital /ID# 143255
Hong Kong, Hong Kong, 999077
Tuen Mun Hospital /ID# 143256
Tuen Mun, Hong Kong, 999077
Hungary
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 143258
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Qualiclinic Kft. /ID# 143259
Budapest, Pest, Hungary, 1036
Markusovszky Egyetemi Oktatókórház /ID# 143261
Szombathely, Vas, Hungary, 9700
Hevizgyogyfurdo es Szent Andra /ID# 143257
Heviz, Hungary, 8380
Pest Megyei Flor Ferenc Korhaz /ID# 143260
Kistarcsa, Hungary, 2143
Fejer Megyei Szent Gyorgy Korh /ID# 144724
Szekesfehervar, Hungary, 8000
Ireland
St Vincent's University Hosp /ID# 143262
Dublin, Ireland, D04 T6F4
Israel
Barzilai Medical Center /ID# 144725
Ashkelon, Israel, 78278
Rambam Health Care Campus /ID# 143263
Haifa, Israel, 3109601
Sheba Medical Center /ID# 145975
Ramat Gan, Israel, 5262100
Italy
Istituto Clinico Humanitas /ID# 147531
Rozzano, Milano, Italy, 20089
Azienda Ospedaliera Luigi Sacc /ID# 143270
Milan, Italy, 20157
Fondazione IRCCS Policlinico /ID# 143265
Pavia, Italy, 27100
A.O.U.I. di Verona Policlinico /ID# 143266
Verona, Italy, 37134
Japan
Nagoya University Hospital /ID# 148031
Nagoya-shi, Aichi, Japan, 466-8560
NHO Toyohashi Medical Center /ID# 161033
Toyohashi-shi, Aichi, Japan, 440-8510
Teikyo University Chiba Medical Center /ID# 159618
Ichihara, Chiba, Japan, 299-0111
NHO Kyushu Medical Center /ID# 148263
Fukuoka-shi, Fukuoka, Japan, 810-8563
NHO Kyushu Medical Center /ID# 148264
Fukuoka-shi, Fukuoka, Japan, 810-8563
National Hospital Organization Asahikawa Medical Center /ID# 148021
Asahikawa, Hokkaido, Japan, 070-8644
Katayama Orthopedic Rheumatology Clinic /ID# 148029
Asahikawa, Hokkaido, Japan, 078-8243
Kobe University Hospital /ID# 153461
Kobe, Hyogo, Japan, 650-0017
National Hospital Organization Sagamihara National Hospital /ID# 148019
Sagamihara-shi, Kanagawa, Japan, 252-0315
NHO Osaka Minami Med Ctr /ID# 148042
Osaka, Kawachinagano-shi, Japan, 586-8521
Bay Side Misato Medical Center /ID# 148256
Kochi-shi, Kochi, Japan, 781-0112
Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148254
Kumamoto-shi, Kumamoto, Japan, 862-0920
Kumamoto Orthopaedic Hospital /ID# 148054
Kumamoto-shi, Kumamoto, Japan, 862-0976
Kumamoto Shinto General Hospital /ID# 148266
Kumamoto-shi, Kumamoto, Japan, 8628655
Sasebo Chuo Hospital /ID# 148261
Sasebo-city, Nagasaki, Japan, 857-1195
Nagaoka Red Cross Hospital /ID# 148018
Nagaoka-shi, Niigata, Japan, 940-2108
Japanese Red Cross Okayama Hospital /ID# 159619
Okayama-shi, Okayama, Japan, 7008607
Kansai Medical University Hospital /ID# 159622
Hirakata-shi, Osaka, Japan, 573-1191
Osaka Medical College Hospital /ID# 159624
Takatsuki -shi, Osaka, Japan, 569-8686
Saitama Medical Center, Saitama Medical University /ID# 148015
Kawagoe-shi, Saitama, Japan, 350-8550
Jichi Medical University Hospital /ID# 159620
Shimotsuke-shi, Tochigi, Japan, 329-0498
Juntendo University Hospital /ID# 148050
Bunkyo-ku, Tokyo, Japan, 113-8431
St.Luke's International Hospital /ID# 148041
Chuo-ku, Tokyo, Japan, 104-8560
Toho University Ohashi Medical Center /ID# 148027
Meguro-ku, Tokyo, Japan, 1538515
Keio University Hospital /ID# 148057
Shinjuku-ku, Tokyo, Japan, 160-8582
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 148052
Shimonoseki-shi, Yamaguchi, Japan, 752-0976
National Hospital Organization Beppu Medical Center /ID# 161058
Beppu, Japan, 874 - 001
NHO Chiba-East-Hospital /ID# 148035
Chiba, Japan, 260-8712
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 148047
Fukui, Japan, 910-0068
Shono Rheumatism Clinic /ID# 148046
Fukuoka, Japan, 814-0002
Matsubara Mayflower Hospital /ID# 148033
Kato, Japan, 673-1462
St. Mary's Hospital /ID# 148038
Kurume, Japan, 830-8543
Kagawa University Hospital /ID# 148016
Kyoto, Japan, 615-8256
Yu Family Clinic /ID# 148048
Miyagi, Japan, 981-0112
Daido Hospital /ID# 160868
Nagoya, Japan, 457-8511
Kondo Clinic for Ortho & Rheum /ID# 148032
Nagoya, Japan, 464-0071
Shirahama Hamayu Hospital /ID# 148253
Nishimura, Japan, 649-2211
Oribe Clinic of Rheumatology and Internal Medicine /ID# 156035
Oita, Japan, 870-0823
Osaka City General Hospital /ID# 159617
Osaka, Japan, 534-0021
Sanuki Municipal Hospital /ID# 158842
Sanuki, Japan, 769-2321
Sagawa Akira Rheumatology Clin /ID# 148043
Sapporo, Japan, 060-0001
Sapporo City General Hospital /ID# 148037
Sapporo, Japan, 060-8604
Hokkaido University Hospital /ID# 148262
Sapporo, Japan, 060-8648
Hokkaido Medical Center for Rheumatic Diseases /ID# 148259
Sapporo, Japan, 063-0811
Azuma Rheumatology Clinic /ID# 161050
Sayama, Japan, 350-1305
Hikarigaoka Spellman Hospital /ID# 148020
Sendai, Japan, 983-0833
Takaoka Rheumatic Orthopedic Clinic /ID# 148022
Takaoka, Japan, 933-0874
National Hospital Organization Tokyo Medical Center /ID# 148040
Tokyo, Japan, 152-8902
National Hospital Organization Shimoshizu National Hospital /ID# 148258
Yotsukaido, Japan, 284-0003
Kazakhstan
JSC Nat Scientific Med Res Ctr /ID# 143272
Astana, Kazakhstan, 010009
Karaganda State Medical Univ /ID# 153431
Karaganda, Kazakhstan, 100008
Semey State Medical University /ID# 152661
Semey, Kazakhstan, 071403
Regional Clinical Hospital /ID# 147173
Shymkent, Kazakhstan, 160000
Latvia
LTD M+M Centers /ID# 143279
Adazi, Latvia, 2164
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 143582
Kaunas, Kovno, Lithuania, 50009
Klaipeda University Hospital /ID# 143583
Klaipeda, Lithuania, 92288
Vilnius University Hospital /ID# 143584
Vilnius, Lithuania, LT-08661
Mexico
Clinstile, S.A. de C.V. /ID# 143591
Cuauhtemoc, Ciudad De Mexico, Mexico, 06700
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 153562
Mexico City, Ciudad De Mexico, Mexico, 11850
Invest y Biomed de Chihuahua /ID# 143595
Chihuahua, Mexico, 31000
RM Pharma Specialists, S.A de C.V /ID# 143593
Mexico City, Mexico, 03100
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 143592
Mexico City, Mexico, 06090
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 143589
Mexico City, Mexico, 11650
Centro Reumatologico de Queret /ID# 149493
Queretaro, Mexico, 76178
New Zealand
Waikato Hospital /ID# 143602
Hamilton, Waikato, New Zealand, 3204
Middlemore Clinical Trials /ID# 143600
Auckland, New Zealand, 2025
Porter Rheumatology Ltd /ID# 143601
Nelson, New Zealand, 7010
Timaru Medical Specialists Ltd /ID# 143599
Timaru, New Zealand, 7910
Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 143606
Wrocław, Dolnoslaskie, Poland, 51-685
Centrum Medyczne AMED /ID# 143604
Warsaw, Mazowieckie, Poland, 01-518
Centrum Medyczne Pratia Warszawa /ID# 143608
Warsaw, Mazowieckie, Poland, 01-869
Centrum Medyczne Pratia Gdynia /ID# 143607
Gdynia, Pomorskie, Poland, 81-338
Silmedic Sp z o.o /ID# 143605
Katowice, Slaskie, Poland, 40-282
NZOZ Centrum Reumatologiczne /ID# 143603
Elblag, Warminsko-mazurskie, Poland, 82-300
Medyczne Centrum Hetmanska /ID# 144726
Poznań, Wielkopolskie, Poland, 60-218
Portugal
Instituto Portugues De Reumatologia /ID# 148313
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar Lisboa Ocidental, EPE /ID# 151009
Lisbon, Lisboa, Portugal, 1349-019
Centro Hospitalar De Vila Nova /ID# 143615
Vila Nova De Gaia, Porto, Portugal, 4434-502
Centro Hospitalar Lisboa Norte, EPE /ID# 143613
Lisboa, Portugal, 1649-035
Centro Hospitalar Baixo Vouga /ID# 153726
Porto, Portugal, 4050-111
Centro Hospitalar de Sao Joao, EPE /ID# 153575
Porto, Portugal, 4200-319
Unidade Local De Saude Do Alto Minho /ID# 143611
Viana Do Castelo, Portugal, 4901-858
Centro Hosp de Tondela-Viseu /ID# 143612
Viseu, Portugal, 3504-509
Puerto Rico
Ponce School of Medicine /ID# 145657
Ponce, Puerto Rico, 00716
GCM Medical Group /ID# 143618
San Juan, Puerto Rico, 00909
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 143619
San Juan, Puerto Rico, 00935
Romania
Spitalul Clinic Dr. I. Cantacuzino /ID# 143622
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Sf. Maria /ID# 143623
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 143625
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 143627
Bucuresti, Romania, 011172
Spitalul Clinic de Recuperare /ID# 143620
Iasi, Romania, 700656
Ecomed SRL /ID# 143629
Oradea, Romania, 410028
Russian Federation
Family Outpatient clinic#4,LLC /ID# 151010
Korolev, Moskva, Russian Federation, 141060
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143641
Moscow, Moskva, Russian Federation, 119049
LLC Medical Center /ID# 143647
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
LLC Novaya Klinika /ID# 143631
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Kazan State Medical University /ID# 143645
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Tver Regional Clinical Hosp. /ID# 143639
Tver, Tverskaya Oblast, Russian Federation, 170036
Russian National Research Medi /ID# 143642
Moscow, Russian Federation, 117997
Orenburg Regional Clinical Hos /ID# 143630
Orenburg, Russian Federation, 460018
Republican Clin Hos n.a. Baran /ID# 143634
Petrozavodsk, Russian Federation, 185019
Ryazan State Medical Universit /ID# 143646
Ryazan, Russian Federation, 390026
Samara Regional Clinical Hosp /ID# 150928
Samara, Russian Federation, 443095
Reg Clin Hosp n.a. Kuvatova G. /ID# 143632
UFA, Russian Federation, 450005
Ulyanovsk Regional Clin Hosp /ID# 143644
Ulyanovsk, Russian Federation, 432018
Voronezh State Medical Univers /ID# 150926
Voronezh, Russian Federation, 394036
Serbia
Clinical Center Serbia /ID# 143649
Belgrade, Beograd, Serbia, 11000
Clinical Center Serbia /ID# 143650
Belgrade, Beograd, Serbia, 11000
Special Hospital for Rheuma /ID# 143648
Novi Sad, Vojvodina, Serbia, 21000
Slovakia
MEDMAN s.r.o. /ID# 143661
Martin, Slovakia, 036 01
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 143657
Nové Mesto Nad Váhom, Slovakia, 915 01
REUMACENTRUM s.r.o. /ID# 143653
Partizanske, Slovakia, 958 01
Slovak research center Team Member, Thermium s.r.o. /ID# 143663
Pieštany, Slovakia, 921 01
Slovak Research Center /ID# 143659
Puchov, Slovakia, 02001
TIMMED spol. s r.o. /ID# 143664
Stará Lubovna, Slovakia, 06401
Reumatologicka ambulancia, LER /ID# 143660
Topolcany, Slovakia, 955 01
MEDEOS s.r.o. /ID# 143656
Trencin, Slovakia, 91101
REUMA-GLOBAL, s.r.o. /ID# 143655
Trnava, Slovakia, 91701
ALBAMED s.r.o. /ID# 143654
Zvolen, Slovakia, 960 01
Reuma -MUDr. Maria Palasthyova /ID# 143662
Žiar nad Hronom, Slovakia, 965 01
Slovenia
Univ Medical Ctr Ljubljana /ID# 143667
Ljubljana, Slovenia, 1000
South Africa
Jakaranda Hosp, Emmed Research /ID# 143668
Pretoria, Gauteng, South Africa, 0132
Jakaranda Hosp, Emmed Research /ID# 145976
Pretoria, Gauteng, South Africa, 0132
Arthritis Clinical Research Tr /ID# 143670
Cape Town, Western Cape, South Africa, 7405
Winelands Medical Research Ctr /ID# 143669
Stellenbosch, Western Cape, South Africa, 7600
Spain
H. Un. Marques de Valdecilla /ID# 143671
Santander, Cantabria, Spain, 39008
Comple Hosp Univ de A Coruna /ID# 143672
A Coruna, Spain, 15006
Hospital Univ Vall d'Hebron /ID# 143675
Barcelona, Spain, 08035
Hospital Clin Univ San Carlos /ID# 143674
Madrid, Spain, 28040
Clinica Gaias /ID# 143673
Santiago de Compostela, Spain, 15702
Hosp Nuestra Senora Esperanza /ID# 143677
Santiago de Compostela, Spain, 15705
Switzerland
HFR Fribourg - Hopital Canton /ID# 143700
Fribourg, Switzerland, 1708
Taiwan
China Medical University Hosp /ID# 143703
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 143702
Taipei City, Taipei, Taiwan, 10002
Dalin Tzu Chi General Hospital /ID# 153535
Dalin, Taiwan, 622
Tunisia
Hopital Mongi Slim /ID# 152870
La Marsa, Tunisia, 2046
Institut Mohamed Kassab /ID# 152869
Manouba, Tunisia, 2010
Hopital Farhat Hached /ID# 152868
Sousse, Tunisia, 4000
Charles Nicolle Univ Hosp /ID# 152866
Tunis, Tunisia, 1006
Hospital La Rabta /ID# 152867
Tunis, Tunisia, 1007
Turkey
Uludag Universitesi Ataturk Rehabilitasyon ve Uygulama Merkezi /ID# 143705
Osmangazi, Bursa, Turkey, 16080
Izmir Tepecik Training and Research Hospital /ID# 157863
Konak, Izmir, Turkey, 35180
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143704
Izmir, Turkey, 35360
Ukraine
Lviv Regional Clinical Hospita /ID# 154449
Lviv, Lvivska Oblast, Ukraine, 79013
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143714
Vinnytsia, Vinnytska Oblast, Ukraine, 21018
Regional Clinical Hospital /ID# 152029
Ivano-frankivsk, Ukraine, 76018
NSC-Strazhesko Ist Cardiology /ID# 152026
Kiev, Ukraine, 03680
LLC Revmocentr /ID# 143710
Kyiv, Ukraine, 04070
MNCE "Lviv City Clinical Hospital #4" /ID# 143711
Lviv, Ukraine, 79007
Odessa National Medical Univ /ID# 143715
Odesa, Ukraine, 65026
Zaporizhzhia Regional Clinical /ID# 143712
Zaporizhia, Ukraine, 69600
United Kingdom
Leicester Royal Infirmary /ID# 143718
Leicester, England, United Kingdom, LE1 5WW
Whipps Cross Univ Hospital /ID# 143721
London, London, City Of, United Kingdom, E11 1NR
Western General Hospital /ID# 144431
Edinburgh, United Kingdom, EH4 2XU
Chapel Allerton Hospital /ID# 143717
Leeds, United Kingdom, LS7 4SA
Queen Alexandra Hospital /ID# 143722
Portsmouth, United Kingdom, PO6 3LY
Southampton General Hospital /ID# 143716
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

AbbVie

Investigators

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Study Director:	AbbVie Inc.	AbbVie

Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol [PDF] December 26, 2017

Statistical Analysis Plan [PDF] April 16, 2018

More Information

Additional Information:

Related Info. This link exits the ClinicalTrials.gov site

Publications:

van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed MF, Chen S, Rischmueller M, Blanco R, Xavier RM, Strand V. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020 Oct;72(10):1607-1620. doi: 10.1002/art.41384. Epub 2020 Sep 8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861.

Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

Strand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.

Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83.

Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

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Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT02706873
Other Study ID Numbers:	M13-545 2015-003334-27 ( EudraCT Number )
First Posted:	March 11, 2016 Key Record Dates
Results First Posted:	October 4, 2019
Last Update Posted:	December 5, 2022
Last Verified:	December 2022
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:


Musculoskeletal disease Arthritis Joint disease Anti-inflammatory agents	Antirheumatic agents ABT-494 Upadacitinib

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 Methotrexate Upadacitinib Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Janus Kinase Inhibitors Protein Kinase Inhibitors

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