Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Rituximab

Tumor Necrosis Factor Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

Rituximab administered according to prescribing information and normal clinical practice.

Clinical Trials

This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.

An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)

DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.

EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline \>1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline \>1.2 with a DAS28 score of \>3.2, or decrease from baseline \>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline \>0.6 and ≤1.2 with a DAS28 score of \>5.1.

SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.

TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. A decrease from baseline indicates improvement.

ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.

C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.

Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.

Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.

The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.

Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.

Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Percentage of non-serious ADRs at the time of study completion was reported.

An ADR was defined as any noxious and unintended response to a medicinal product related to any dose.

Percentage of serious AEs resolved and ongoing at the time of study completion was reported.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Percentage of serious ADRs resolved and ongoing at the time of study completion was reported.

An ADR was defined as any noxious and unintended response to a medicinal product related to any dose.

Hoffmann-La Roche

Safety population, defined as all enrolled participants who received at least one dose of rituximab.

Age, Continuous

Sex: Female, Male

Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.

Medical Communications

Baseline

Change at Month 6

Change at Month 12

Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12

Overall - Month 6

Good Response - Month 6

Moderate Response - Month 6

No Response - Month 6

Overall - Month 12

Good Response - Month 12

Moderate Response - Month 12

No Response - Month 12

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12

Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12

Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12

Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.

Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12

Remained on treatment - Month 6

Discontinued treatment - Month 6

Remained on treatment - Month 12

Discontinued treatment - Month 12

Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12

Disease remission

Lost to follow-up

Adverse reaction (Allergic reaction)

Switched physician

Insurance issues

Lack of response

Investigation of reasons for body weight loss

Reasons for Discontinuation of Treatment by Month 6

Lack of efficacy

Non-satisfactory response

Adverse reactions (Bradycardia and dermatitis)

Patient's decision due to adverse event

Physician's decision

Reasons for Discontinuation of Treatment by Month 12

Baseline to Month 6 (n = 89)

Baseline to Month 12 (n = 97)

Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.

Spots Global Cancer Trial Database for An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial