- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592292
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
July 6, 2016 updated by: Hoffmann-La Roche
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy.
Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy.
Data will be collected for 12 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of, 48108
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Daegu, Korea, Republic of, 41931
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Daegu, Korea, Republic of, 42472
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Daejeon, Korea, Republic of, 302-799
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Gwangju, Korea, Republic of, 61469
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Gyeonggi-do, Korea, Republic of, 10380
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Jeju Special Self-Governing Province, Korea, Republic of, 63241
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Jeollabuk-do, Korea, Republic of, 561-712
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Seoul, Korea, Republic of, 150-713
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Seoul, Korea, Republic of, 130-702
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Seoul, Korea, Republic of, 05030
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Seoul, Korea, Republic of, 06273
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Seoul, Korea, Republic of, 134-722
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Suwon, Korea, Republic of, 442-723
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Ulsan, Korea, Republic of, 44033
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.
Description
Inclusion Criteria:
- Adult participants, >/=20 years of age
- Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion Criteria:
- Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Participants who have not signed the informed consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
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Rituximab as per physician's discretion.
Other Names:
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Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
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Adalimumab as per physician's discretion.
Etanercept as per physician's discretion.
Infliximab as per physician's discretion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Time Frame: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Time Frame: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Time Frame: Baseline and Month 12
|
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Time Frame: Baseline, Month 6 and 12
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TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Time Frame: Baseline, Month 6 and 12
|
TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
|
Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Time Frame: Baseline, Month 6 and 12
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SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
|
Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Time Frame: Baseline, Month 6 and 12
|
SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Time Frame: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Time Frame: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Time Frame: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Time Frame: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
Time Frame: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
Time Frame: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Time Frame: Baseline up to Month 12
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
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Baseline up to Month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 11, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
August 22, 2016
Last Update Submitted That Met QC Criteria
July 6, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Etanercept
- Adalimumab
- Rituximab
- Infliximab
Other Study ID Numbers
- ML27923
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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