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A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
methotrexate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • patients >=18 years with moderate to severe active RA for at least 6 months;
  • swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
  • inadequate response to stable dose of MTX;
  • patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA;
  • patients with functional class IV RA;
  • diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
  • prior treatment failure with anti-tumor necrosis factor agent;
  • pregnant or breastfeeding women.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments: Participant's global assessment of pain by Visual Analog Scale (VAS) Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)

Secondary Outcome Measures

Percentage of Participants With ACR20 and ACR70 Response at Week 24
ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain by VAS Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by HAQ-DI Acute phase reactant (ESR or CRP)
Time to Onset of ACR20, ACR50, and ACR70
ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain by VAS Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by HAQ-DI Acute phase reactant (ESR or CRP)
Change From Baseline in Hemoglobin at Week 24
SJC and TJC at Baseline and Week 24
The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).
Percent Change From Baseline in SJC and TJC at Week 24
The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).
Pain as Assessed by the Participant at Baseline and Week 24
The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement.
Percent Change From Baseline in Pain as Assessed by the Participant at Week 24
The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement.
Participant's Global Assessment of Disease Activity at Baseline and Week 24
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity).
Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity).
Physician's Global Assessment of Disease Activity at Baseline and Week 24
The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity).
Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24
The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity).
HAQ-DI at Baseline and Week 24
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).
Percent Change From Baseline in HAQ-DI at Week 24
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).
Area Under The Curve (AUC) of the ACR(n)
ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.
Percentage of Participants Achieving ACR20 Response
ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain (VAS) Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP
Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models
The probability of ACR positive response was determined using the GEE.
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24
DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.
Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24
DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.
AUC of DAS28
The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.
Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission
Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF

Full Information

First Posted
September 17, 2008
Last Updated
May 13, 2015
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00754572
Brief Title
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official Title
A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8mg/kg iv, every 4 weeks
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
10-25mg oral or parenteral weekly.
Primary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Description
ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments: Participant's global assessment of pain by Visual Analog Scale (VAS) Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With ACR20 and ACR70 Response at Week 24
Description
ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain by VAS Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by HAQ-DI Acute phase reactant (ESR or CRP)
Time Frame
Week 24
Title
Time to Onset of ACR20, ACR50, and ACR70
Description
ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain by VAS Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by HAQ-DI Acute phase reactant (ESR or CRP)
Time Frame
Baseline and Week 24
Title
Change From Baseline in Hemoglobin at Week 24
Time Frame
Baseline and Week 24
Title
SJC and TJC at Baseline and Week 24
Description
The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in SJC and TJC at Week 24
Description
The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).
Time Frame
Baseline and Week 24
Title
Pain as Assessed by the Participant at Baseline and Week 24
Description
The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement.
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Pain as Assessed by the Participant at Week 24
Description
The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement.
Time Frame
Baseline and Week 24
Title
Participant's Global Assessment of Disease Activity at Baseline and Week 24
Description
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity).
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24
Description
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity).
Time Frame
Baseline and Week 24
Title
Physician's Global Assessment of Disease Activity at Baseline and Week 24
Description
The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity).
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24
Description
The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity).
Time Frame
Baseline and Week 24
Title
HAQ-DI at Baseline and Week 24
Description
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in HAQ-DI at Week 24
Description
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).
Time Frame
Baseline and Week 24
Title
Area Under The Curve (AUC) of the ACR(n)
Description
ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Title
Percentage of Participants Achieving ACR20 Response
Description
ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments: Participant's global assessment of pain (VAS) Participant's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP
Time Frame
Week 2
Title
Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models
Description
The probability of ACR positive response was determined using the GEE.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24
Description
DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24
Description
DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.
Time Frame
Week 24
Title
AUC of DAS28
Description
The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.
Time Frame
Weeks 2, 4, 8, 12, 16, 20 and 24
Title
Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24
Description
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Time Frame
Week 24
Title
Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24
Description
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission
Time Frame
Week 24
Title
Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame
Week 24
Title
Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients >=18 years with moderate to severe active RA for at least 6 months; swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening; inadequate response to stable dose of MTX; patients of reproductive potential must be using a reliable means of contraception. Exclusion Criteria: rheumatic autoimmune disease other than RA; patients with functional class IV RA; diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA; prior treatment failure with anti-tumor necrosis factor agent; pregnant or breastfeeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425ASQ
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1426AAL
Country
Argentina
City
Córdoba
ZIP/Postal Code
X5000FAL
Country
Argentina
City
San Miguel De Tucuman
ZIP/Postal Code
T4000IFP
Country
Argentina
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60170001
Country
Brazil
City
Brasilia
State/Province
DF
ZIP/Postal Code
70840-901
Country
Brazil
City
Vitoria
State/Province
ES
ZIP/Postal Code
29043-910
Country
Brazil
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010-570
Country
Brazil
City
Recife
State/Province
PE
ZIP/Postal Code
50000-000
Country
Brazil
City
Curtiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20551-030
Country
Brazil
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95070-560
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88040-970
Country
Brazil
City
Botucatu
State/Province
SP
ZIP/Postal Code
18600-400
Country
Brazil
City
Campinas
State/Province
SP
ZIP/Postal Code
13059-900
Country
Brazil
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-888
Country
Brazil
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04027-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-004
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
City
Concepcion
ZIP/Postal Code
1436
Country
Chile
City
Santiago
ZIP/Postal Code
352
Country
Chile
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
City
Santiago
ZIP/Postal Code
7550000
Country
Chile
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
City
Santiago
ZIP/Postal Code
8380000
Country
Chile
City
Santiago
ZIP/Postal Code
8860000
Country
Chile
City
Temuco
ZIP/Postal Code
4780000
Country
Chile
City
Barranquilla
Country
Colombia
City
Bogota
ZIP/Postal Code
49 00
Country
Colombia
City
Bogota
Country
Colombia
City
Bogotá
Country
Colombia
City
Bucaramanga
ZIP/Postal Code
0
Country
Colombia
City
Cali
Country
Colombia
City
Chia-Cundinamarca
Country
Colombia
City
Medellin
Country
Colombia
City
Medellín
ZIP/Postal Code
0
Country
Colombia
City
Cartago
ZIP/Postal Code
0
Country
Costa Rica
City
Heredia
ZIP/Postal Code
00
Country
Costa Rica
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
City
San José
Country
Costa Rica
City
Cuenca
Country
Ecuador
City
Guayaquil
Country
Ecuador
City
Quito
ZIP/Postal Code
EC170517
Country
Ecuador
City
Quito
Country
Ecuador
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
City
Mexico City
ZIP/Postal Code
03900
Country
Mexico
City
Mexico City
ZIP/Postal Code
11850
Country
Mexico
City
Mexico City
ZIP/Postal Code
14140
Country
Mexico
City
Miexico City
ZIP/Postal Code
06700
Country
Mexico
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
City
Jesus Maria
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 14
Country
Peru
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
City
Montevideo
ZIP/Postal Code
11000
Country
Uruguay
City
Barquisimeto
ZIP/Postal Code
3005
Country
Venezuela
City
Caracas
ZIP/Postal Code
1010
Country
Venezuela
City
Caracas
ZIP/Postal Code
1040
Country
Venezuela
City
Maracaibo
ZIP/Postal Code
4001
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

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