Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592292
First received: April 11, 2012
Last updated: July 6, 2016
Last verified: March 2016

April 11, 2012
July 6, 2016
November 2011
December 2014   (final data collection date for primary outcome measure)
  • Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.
  • Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.
Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01592292 on ClinicalTrials.gov Archive Site
  • Efficacy: Mean Change From Baseline in DAS28 at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
  • 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 ] [ Designated as safety issue: No ]
    ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.
  • Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.
  • Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events [ Time Frame: Baseline up to Month 12 ] [ Designated as safety issue: No ]
    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.
  • Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in tender joint count (TJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in swollen joint count (SJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean change over time in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean Quality of Life score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.
Rheumatoid Arthritis
  • Drug: Rituximab
    Rituximab as per physician's discretion.
    Other Name: Mabthera
  • Drug: Adalimumab
    Adalimumab as per physician's discretion.
  • Drug: Etanercept
    Etanercept as per physician's discretion.
  • Drug: Infliximab
    Infliximab as per physician's discretion.
  • 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.
    Intervention: Drug: Rituximab
  • 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.
    Interventions:
    • Drug: Adalimumab
    • Drug: Etanercept
    • Drug: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01592292
ML27923
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP