Rheumatoid Arthritis
Conditions
Brief summary
This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.
Interventions
DRUGRituximab
Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Participants receiving rituximab no longer than 4 weeks before the start of monitoring
Exclusion criteria
-Not Applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion | Baseline, 24 weeks after first rituximab infusion (Week 24) | DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With European League Against Rheumatism (EULAR) Good Response | Baseline, Weeks 24, 48 and 72 | Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated by following formula: (0.56\*√TJC)+(0.28\*√SJC)+(0.70\*ln ESR)+(0.014\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\</=3.2; reduction of DAS28 \>1.2. |
Countries
Serbia
Participant flow
Pre-assignment details
There was no documentation for the reason for discontinuation; hence, in Participant Flow module, for all participants who did not complete the study, the reason is reported as Unspecified.
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Participants Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 36 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis Participants |
|---|---|
| Age, Continuous | 51.28 Years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 11 / 130 |
Outcome results
Primary
Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion
DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.
Time frame: Baseline, 24 weeks after first rituximab infusion (Week 24)
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion | 61.60 Percentage of participants |
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated by following formula: (0.56\*√TJC)+(0.28\*√SJC)+(0.70\*ln ESR)+(0.014\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\</=3.2; reduction of DAS28 \>1.2.
Time frame: Baseline, Weeks 24, 48 and 72
Population: ITT Population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response | Week 24 (n=112) | 21.43 Percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response | Week 48 (n=81) | 16.05 Percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response | Week 72 (n=59) | 18.64 Percentage of participants |