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A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis

A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01640548
Enrollment
320
Registered
2012-07-13
Start date
2012-09-30
Completion date
2013-06-30
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This non-interventional, retrospective, cross sectional chart review study will evaluate the management of rheumatoid arthritis patients with a biologic in monotherapy. Data from eligible patients will be collected from the patient's last visit on the prior rheumatoid arthritis treatment and from the most recent visit for the biological monotherapy.

Interventions

None listed

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients, \>/= 18 years of age * Diagnosis of rheumatoid arthritis by a Rheumatologist * Patient being prescribed with a biologic in monotherapy

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy9 monthsBoth previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.
Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD9 monthsbDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.
Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD9 monthsTraditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.
Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD9 monthsbDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (\> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.
Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy9 monthsbDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (\> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.
Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment9 monthsAll corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.

Secondary

MeasureTime frameDescription
Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods9 monthsDAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.
Duration of Treatment With the Current bDMARD Usage in Monotherapy9 months
Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA9 months
Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA9 months
Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)9 monthsDAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Rheumatoid Arthritis Cohort
Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
309
Total309

Baseline characteristics

CharacteristicRheumatoid Arthritis Cohort
Age, Continuous61.8 years
STANDARD_DEVIATION 11.99
Gender
Female
224 Participants
Gender
Male
85 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
6 / 71
serious
Total, serious adverse events
3 / 71

Outcome results

Primary

Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy

Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.

Time frame: 9 months

Population: Included all participants who entered the retrospective chart review.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage of Participants by Reason for Choosing Previous and Current bDMARDs in MonotherapyPhysician's preference/experience/Unknown84.1 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants by Reason for Choosing Previous and Current bDMARDs in MonotherapyParticipant preference5.8 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants by Reason for Choosing Previous and Current bDMARDs in MonotherapyContra-indication to alternative drug4.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants by Reason for Choosing Previous and Current bDMARDs in MonotherapyOther8.4 percentage of participants
Primary

Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD

bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.

Time frame: 9 months

Population: Included all the participants who entered the retrospective chart review.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDEtanercept39.5 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDAdalimumab28.8 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDTocilizumab12.3 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDRituximab10.7 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDCertolizumab Pegol6.1 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDInfliximab1.0 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDGolimumab1.0 percentage of participants
Rheumatoid Arthritis CohortPercentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARDAbatacept0.6 percentage of participants
Primary

Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD

Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.

Time frame: 9 months

Population: Included all the participants who took any past traditional DMARDs.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDMethotrexate94.7 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDSulfasalazine78.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDLeflunomide46.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDHydroxychloroquine42.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDGold Compounds29.4 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDPenicillamine9.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDCyclosporine9.2 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDAzathioprine8.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDChlorambucil0.3 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDMercaptopurine0.3 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARDMycophenolate Mofetil0.3 percentage of participants
Primary

Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD

bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (\> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.

Time frame: 9 months

Population: Included participants who were previously treated with any bDMARD with concomitant traditional DMARD prior to switch to bDMARD monotherapy as current RA treatment.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDEtanercept51.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDAdalimumab45.0 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDRituximab16.8 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDInfliximab15.3 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDTocilizumab9.2 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDAbatacept1.5 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARDAnakinra0.8 percentage of participants
Primary

Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy

bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (\> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.

Time frame: 9 months

Population: Included participants who received bDMARD as monotherapy as previous treatment prior to switch to bDMARD monotherapy as current treatment.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD MonotherapyEtanercept53.0 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD MonotherapyAdalimumab41.9 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD MonotherapyCertolizumab Pegol13.7 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD MonotherapyRituximab11.1 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD MonotherapyTocilizumab6.0 percentage of participants
Primary

Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment

All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.

Time frame: 9 months

Population: Included all the participants who entered the retrospective chart review.

ArmMeasureGroupValue (NUMBER)
Rheumatoid Arthritis CohortPercentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of TreatmentParticipants with any previous treatment for RA96.1 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of TreatmentNon-steroidal anti-inflammatories83.8 percentage of participants
Rheumatoid Arthritis CohortPercentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of TreatmentCorticosteroids77.3 percentage of participants
Secondary

Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)

DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.

Time frame: 9 months

Population: Included the number of participants who were evaluable for DAS28 assessment. n represents the number of participants who were evaluable for that particular assessment.

ArmMeasureGroupValue (MEAN)
Rheumatoid Arthritis CohortAssessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)ESR-DAS28 score (n=149)3.41 scores on a scale
Rheumatoid Arthritis CohortAssessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)CRP-DAS28 score (n=72)3.21 scores on a scale
Secondary

Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA

Time frame: 9 months

Population: Included participants who were treated with a bDMARD with concomitant traditional DMARD as previous treatment for RA. n is the number of participants who received particular bDMARD as previous RA treatment.

ArmMeasureGroupValue (MEDIAN)
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RAAbatacept (n=2)4.10 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RAAdalimumab (n=62)18.60 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RAAnakinra (n=1)9.50 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RAEtanercept (n=72)15.95 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RAInfliximab (n=21)10.00 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RARituximab (n=41)0.00 months
Rheumatoid Arthritis CohortDuration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RATocilizumab (n=15)3.40 months
Secondary

Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA

Time frame: 9 months

Population: Included participants treated with a bDMARD monotherapy as previous treatment for RA prior to switch to current bDMARD monotherapy. n is the number of participants who received particular bDMARD as previous RA treatment.

ArmMeasureGroupValue (MEDIAN)
Rheumatoid Arthritis CohortDuration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RAAdalimumab (n=56)8.55 months
Rheumatoid Arthritis CohortDuration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RACertolizumab Pegol (n=16)0.90 months
Rheumatoid Arthritis CohortDuration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RAEtanercept (n=82)10.50 months
Rheumatoid Arthritis CohortDuration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RARituximab (n=14)4.25 months
Rheumatoid Arthritis CohortDuration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RATocilizumab (n=7)7.80 months
Secondary

Duration of Treatment With the Current bDMARD Usage in Monotherapy

Time frame: 9 months

Population: Included all participants who received bDMARD monotherapy as their current treatment for RA. n is the number of participants who received that particular bDMARD as their current RA treatment.

ArmMeasureGroupValue (MEDIAN)
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyAbatacept (n=2)38.70 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyAdalimumab (n=89)41.70 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyCertolizumab Pegol (n=19)13.20 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyEtanercept (n=121)36.20 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyGolimumab (n=3)6.60 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyInfliximab (n=3)13.60 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyRituximab (n=33)18.20 months
Rheumatoid Arthritis CohortDuration of Treatment With the Current bDMARD Usage in MonotherapyTocilizumab (n=38)12.05 months
Secondary

Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods

DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.

Time frame: 9 months

Population: Includes all participants who were evaluable for this outcome. n represents the number of participants who were evaluable for that particular assessment.

ArmMeasureGroupValue (MEAN)
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsESR-TJC (n=164)3.2 joints count
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsESR-SJC (n=163)1.6 joints count
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsESR-Non-evaluable DAS28 joints (n=125)0.4 joints count
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsCRP-TJC (n=73)3.7 joints count
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsCRP-SJC (n=74)2.3 joints count
Rheumatoid Arthritis CohortTotal Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP MethodsCRP-Non-evaluable DAS28 joints (n=30)0.5 joints count

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026