Rheumatoid Arthritis
Conditions
Brief summary
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs * Patients treated with biologic DMARDs alone for at least 6 months
Exclusion criteria
* Patients not willing or unable to give written informed consent for participation in this study * Patients who are participating in any clinical trial at the time of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Level of Education Completed | At Visit 1 (Single visit study) | Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study) |
| Number of Participants With Smoking Habits | At Visit 1 | Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1. |
| Smoking-habit for Smokers or Ex-smokers (Packs in Years) | At Visit 1 | Smoking-habit included number of pack per years is reported. |
| Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) | At Visit 1 | Smoking-habit included years of smoking/quit smoking is reported for participants. |
| Mean Time of Onset of Rheumatoid Arthritis | At Visit 1 | Onset of rheumatoid arthritis is a component of clinical characteristics. |
| Number of Participants With Family History of Rheumatoid Arthritis | At Visit 1 | Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded. |
| Number of Participants With Co-morbidities | At Visit 1 | Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no. |
| Number of Participants With Extra-articular Manifestations at Visit 1 | At Visit 1 | Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos. |
| Mean Number of Painful and Swollen Joints at Visit 1 | At Visit 1 | Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. |
| Physician's Global Assessment of Disease Activity at Visit 1 | At Visit 1 | The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). |
| Patient's Global Assessment of Disease Activity at Visit 1 | At Visit 1 | Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). |
| Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | At Visit 1 | Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes. |
| Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | At Visit 1 | Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids. |
| Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | At Visit 1 | Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. |
| Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 | At Visit 1 | The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation. |
| Patient Pain Visual Analog Scale Score at Visit 1 | At Visit 1 | Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain |
| Number of Participants With Joint Damage at Visit 1 | At Visit 1 | Number of participants with joint damage is recorded as yes and no. |
| Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1 | At Visit 1 | Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. |
| Number of Participants With Disease Activity Score by Categorization at Visit 1 | At Visit 1 | DAS28 is divided into 4 categories as: remission \<2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high \>5.1. |
| Mean Score on Clinical Disease Activity Index at Visit 1 | At Visit 1 | Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity. |
| Number of Participants With Clinical Disease Activity by Categorization at Visit 1 | At Visit 1 | CDAI is divided into 4 categories as: remission \<2.8, low activity 2.8-10, moderate 10-22 and high\>22. |
| Mean Score on Simple Disease Activity Index at Visit 1 | At Visit 1 | Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity. |
| Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 | At Visit 1 | SDAI is divided into 4 categories as: remission (\<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (\>26). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Leading to a Change of Treatment | At the time of change of treatment | An Adverse Event was considered as 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. Adverse events were collected as a reason for the change to monotherapy. |
| Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study | At Visit 1 | Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented. |
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | At the time of change of treatment (to the current treatment) | An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. |
| Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug | At Visit 1 | Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented. |
| Number of Participants Who Received Each sDMARD Before The Study | At Visit 1 | Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications. |
| Number of Participants Who Received Last sDMARD Prescribed Before the Study | At Visit 1 | Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate. |
| Number of Participants Prescribed First bDMARD Before the Study | At Visit 1 | Number of participants prescribed first bDMARD before the study was presented. |
| Number of Participants Who Received Each bDMARD Before the Study | At Visit 1 | Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1. |
| Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 | At Visit 1 | Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months. |
| Number of Participants With Changing the Previous sDMARD/ bDMARD | At Visit 1 | Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant. |
| Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) | At Visit 1 | Number of sDMARD and bDMARDs received by Participants before the study was presented |
| Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment | At Visit 1 | — |
| Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | At Visit 1 | The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other. |
| Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | At Visit 1 | Median time in months taking the Biologic Agent in monotherapy before the study was presented. |
| Number of Participants Treated With Concomitant Medications Before the Study | At Visit 1 | Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs \[NSAID\], and other treatment) before the study were presented. |
| Number of Participants Received Current bDMARD Treatment at the Time of the Study | At Visit 1 | Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab. |
| Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy | At Visit 1 | Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID. |
| Number of Participants With Reasons for Starting Current Biologic Monotherapy | At Visit 1 | The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. |
| Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study | At Visit 1 | Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported. |
| Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA | At Visit 1 | — |
| Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) | At Visit 1 | — |
| Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | At Visit 1 | Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study. |
| Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | At Visit 1 | Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study . |
| Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study | At Visit 1 | Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ). |
| Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study | At Visit 1 | Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). |
Countries
Spain
Participant flow
Recruitment details
A total of 210 participants were enrolled from 38 rheumatology units in Spain. This study was conducted between June 2012 and June 2013.
Pre-assignment details
Of 210 participants, one participant was excluded from the study because of past history of biologic disease-modifying antirheumatic drug (bDMARD) monotherapy under 6 months. Therefore, 209 participants were evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| bDMARD Monotherapy Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice. | 209 |
| Total | 209 |
Baseline characteristics
| Characteristic | bDMARD Monotherapy |
|---|---|
| Age, Continuous | 57.61 Years STANDARD_DEVIATION 13.59 |
| Sex: Female, Male Female | 173 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 209 |
| serious Total, serious adverse events | 7 / 209 |
Outcome results
Primary
Mean Number of Painful and Swollen Joints at Visit 1
Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Number of Painful and Swollen Joints at Visit 1 | Painful joints | 1.92 Number of joints | Standard Deviation 3 |
| bDMARD Monotherapy | Mean Number of Painful and Swollen Joints at Visit 1 | Swollen joints | 0.84 Number of joints | Standard Deviation 2.07 |
Primary
Mean Score on Clinical Disease Activity Index at Visit 1
Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Mean Score on Clinical Disease Activity Index at Visit 1 | 8.36 Scores on a scale | Standard Deviation 6.94 |
Primary
Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1
Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1 | 2.70 Units on a scale | Standard Deviation 1.09 |
Primary
Mean Score on Simple Disease Activity Index at Visit 1
Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Mean Score on Simple Disease Activity Index at Visit 1 | 8.76 Scores on a scale | Standard Deviation 7.06 |
Primary
Mean Time of Onset of Rheumatoid Arthritis
Onset of rheumatoid arthritis is a component of clinical characteristics.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Mean Time of Onset of Rheumatoid Arthritis | 13.45 Years | Standard Deviation 8.77 |
Primary
Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1
Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | ALT, n = 184 | 172 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | AST, n = 172 | 162 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | Triglycerides, n = 144 | 130 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | Total cholesterol, n = 156 | 104 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | HDL, n = 101 | 82 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | LDL, n = 102 | 76 Participants |
| bDMARD Monotherapy | Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 | Total lipids, n = 23 | 21 Participants |
Primary
Number of Participants With Clinical Disease Activity by Categorization at Visit 1
CDAI is divided into 4 categories as: remission \<2.8, low activity 2.8-10, moderate 10-22 and high\>22.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Clinical Disease Activity by Categorization at Visit 1 | Remission | 33 Participants |
| bDMARD Monotherapy | Number of Participants With Clinical Disease Activity by Categorization at Visit 1 | Low activity | 118 Participants |
| bDMARD Monotherapy | Number of Participants With Clinical Disease Activity by Categorization at Visit 1 | Moderate activity | 52 Participants |
| bDMARD Monotherapy | Number of Participants With Clinical Disease Activity by Categorization at Visit 1 | High activity | 06 Participants |
Primary
Number of Participants With Co-morbidities
Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Co-morbidities | Yes | 109 Participants |
| bDMARD Monotherapy | Number of Participants With Co-morbidities | No | 100 Participants |
Primary
Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1
The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 | CRP | 180 Participants |
| bDMARD Monotherapy | Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 | ESR | 162 Participants |
Primary
Number of Participants With Disease Activity Score by Categorization at Visit 1
DAS28 is divided into 4 categories as: remission \<2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high \>5.1.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Disease Activity Score by Categorization at Visit 1 | Remission | 104 Participants |
| bDMARD Monotherapy | Number of Participants With Disease Activity Score by Categorization at Visit 1 | Low activity | 43 Participants |
| bDMARD Monotherapy | Number of Participants With Disease Activity Score by Categorization at Visit 1 | Moderate activity | 59 Participants |
| bDMARD Monotherapy | Number of Participants With Disease Activity Score by Categorization at Visit 1 | High activity | 03 Participants |
Primary
Number of Participants With Extra-articular Manifestations at Visit 1
Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Extra-articular Manifestations at Visit 1 | Yes | 59 Participants |
| bDMARD Monotherapy | Number of Participants With Extra-articular Manifestations at Visit 1 | No | 148 Participants |
| bDMARD Monotherapy | Number of Participants With Extra-articular Manifestations at Visit 1 | Missing | 02 Participants |
Primary
Number of Participants With Family History of Rheumatoid Arthritis
Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Family History of Rheumatoid Arthritis | No | 160 Participants |
| bDMARD Monotherapy | Number of Participants With Family History of Rheumatoid Arthritis | Unknown | 34 Participants |
| bDMARD Monotherapy | Number of Participants With Family History of Rheumatoid Arthritis | Yes | 15 Participants |
Primary
Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1
Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | RBC, n = 170 | 145 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | WBC, n = 183 | 159 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Platelets, n = 180 | 165 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Hemoglobin, n = 192 | 173 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Haematocrit, n = 174 | 157 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Neutrophils, n = 180 | 140 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Basophils, n = 169 | 164 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Eosinophils, n = 168 | 153 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Lymphocytes, n = 173 | 150 Participants |
| bDMARD Monotherapy | Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 | Monocytes, n = 168 | 152 Participants |
Primary
Number of Participants With Joint Damage at Visit 1
Number of participants with joint damage is recorded as yes and no.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Joint Damage at Visit 1 | Yes | 154 Participants |
| bDMARD Monotherapy | Number of Participants With Joint Damage at Visit 1 | No | 55 Participants |
Primary
Number of Participants With Level of Education Completed
Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)
Time frame: At Visit 1 (Single visit study)
Population: Analysis population included all enrolled participants who met the screening criteria
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | Missing | 03 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | Cannot read | 01 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | No formal education | 15 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | Primary education or equivalent | 86 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | General secondary education | 59 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | Vocational education | 17 Participants |
| bDMARD Monotherapy | Number of Participants With Level of Education Completed | Higher education or equivalent | 28 Participants |
Primary
Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies
Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | Anti-CCP antibodies - not available | 94 Participants |
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | RF - positive for presence | 125 Participants |
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | RF - negative for presence | 42 Participants |
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | RF - not available | 42 Participants |
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | Anti-CCP antibodies - positive for presence | 80 Participants |
| bDMARD Monotherapy | Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies | Anti-CCP antibodies - negative for presence | 35 Participants |
Primary
Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1
SDAI is divided into 4 categories as: remission (\<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (\>26).
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 | Remission | 42 Participants |
| bDMARD Monotherapy | Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 | Low activity | 110 Participants |
| bDMARD Monotherapy | Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 | High activity | 04 Participants |
| bDMARD Monotherapy | Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 | Moderate activity | 53 Participants |
Primary
Number of Participants With Smoking Habits
Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Smoking Habits | Non-smoker | 170 Participants |
| bDMARD Monotherapy | Number of Participants With Smoking Habits | Smoker | 15 Participants |
| bDMARD Monotherapy | Number of Participants With Smoking Habits | Ex-smoker | 23 Participants |
| bDMARD Monotherapy | Number of Participants With Smoking Habits | Missing | 01 Participants |
Primary
Patient Pain Visual Analog Scale Score at Visit 1
Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Patient Pain Visual Analog Scale Score at Visit 1 | 3.09 Units on a scale | Standard Deviation 2.14 |
Primary
Patient's Global Assessment of Disease Activity at Visit 1
Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity).
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Patient's Global Assessment of Disease Activity at Visit 1 | 3.11 Units on a scale | Standard Deviation 2.13 |
Primary
Physician's Global Assessment of Disease Activity at Visit 1
The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity).
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| bDMARD Monotherapy | Physician's Global Assessment of Disease Activity at Visit 1 | 2.49 Units on a scale | Standard Deviation 1.96 |
Primary
Smoking-habit for Smokers or Ex-smokers (Packs in Years)
Smoking-habit included number of pack per years is reported.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Smoking-habit for Smokers or Ex-smokers (Packs in Years) | Number of pack-years, smoker, n = 15 | 120.20 Years | Standard Deviation 138.33 |
| bDMARD Monotherapy | Smoking-habit for Smokers or Ex-smokers (Packs in Years) | Number of pack-years, ex-smoker, n = 23 | 122.26 Years | Standard Deviation 122.08 |
Primary
Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )
Smoking-habit included years of smoking/quit smoking is reported for participants.
Time frame: At Visit 1
Population: Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) | Years smoking/quit smoking, smoker, n = 15 | 18.73 Years | Standard Deviation 9.84 |
| bDMARD Monotherapy | Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) | Years smoking/quit smoking, ex-smoker, n = 23 | 9.35 Years | Standard Deviation 8.39 |
Secondary
Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study
Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study | Mean number of NPJ | 2.16 Number of joints | Standard Deviation 3.3 |
| bDMARD Monotherapy | Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study | Mean number of NSJ | 0.96 Number of joints | Standard Deviation 2.32 |
| Other Treatments | Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study | Mean number of NSJ | 0.68 Number of joints | Standard Deviation 1.65 |
| Other Treatments | Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study | Mean number of NPJ | 1.57 Number of joints | Standard Deviation 2.51 |
Secondary
Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study
Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | DAS28 | 2.52 Units on a scale | Standard Deviation 1.06 |
| bDMARD Monotherapy | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | CDAI | 8.66 Units on a scale | Standard Deviation 7.3 |
| bDMARD Monotherapy | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | SDAI | 8.94 Units on a scale | Standard Deviation 7.34 |
| Other Treatments | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | SDAI | 8.52 Units on a scale | Standard Deviation 6.67 |
| Other Treatments | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | DAS28 | 2.97 Units on a scale | Standard Deviation 1.07 |
| Other Treatments | Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study | CDAI | 7.94 Units on a scale | Standard Deviation 6.42 |
Secondary
Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug
Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' = number of participants prescribed with first sDMARD or bDMARD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug | sDMARD, n = 209 | 19.53 Months | Standard Deviation 52.75 |
| bDMARD Monotherapy | Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug | bDMARD, n = 126 | 89.81 Months | Standard Deviation 86.35 |
Secondary
Mean Time Between the Last sDMARD and bDMARD Received at Visit 1
Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the inclusion criteria. 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 | sDMARD, n=64 | 9.39 Months | Standard Deviation 19.96 |
| bDMARD Monotherapy | Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 | sDMARD + Biologic agent, n=95 | 1.78 Months | Standard Deviation 9.06 |
| bDMARD Monotherapy | Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 | Monotherapy, n=50 | 36.69 Months | Standard Deviation 32.54 |
Secondary
Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA | Tocilizumab, n = 122 | 11.34 years | Standard Deviation 7.95 |
| bDMARD Monotherapy | Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA | Other, n = 87 | 10.23 years | Standard Deviation 9.3 |
Secondary
Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment
Median time in months taking the Biologic Agent in monotherapy before the study was presented.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Adalimumab, n = 15 | 16 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Abatacept, n = 4 | 18.6 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Tocilizumab, n = 1 | 10.1 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Rituximab, n = 6 | 4.1 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Etanercept, n = 14 | 29.4 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Infliximab, n = 9 | 31.9 Months |
| bDMARD Monotherapy | Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment | Golimumab, n = 1 | 59.5 Months |
Secondary
Number of Participants Discontinued the Previous Treatment and Started the Study Treatment
The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | Lack of efficacy | 128 participants |
| bDMARD Monotherapy | Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | Adverse events | 21 participants |
| bDMARD Monotherapy | Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | Intolerance | 16 participants |
| bDMARD Monotherapy | Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | Clinical improvement | 22 participants |
| bDMARD Monotherapy | Number of Participants Discontinued the Previous Treatment and Started the Study Treatment | Other | 22 participants |
Secondary
Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study
Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study | Falling Within Reference Values For ESR | 108 participants |
| bDMARD Monotherapy | Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study | Falling Within Reference Values For CRP | 110 participants |
| Other Treatments | Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study | Falling Within Reference Values For ESR | 54 participants |
| Other Treatments | Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study | Falling Within Reference Values For CRP | 70 participants |
Secondary
Number of Participants Prescribed First bDMARD Before the Study
Number of participants prescribed first bDMARD before the study was presented.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| bDMARD Monotherapy | Number of Participants Prescribed First bDMARD Before the Study | 126 Participants |
Secondary
Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study
Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study | First sDMARD as monotherapy | 209 Participants |
| bDMARD Monotherapy | Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study | First sDMARD as combination | 27 Participants |
Secondary
Number of Participants Received Current bDMARD Treatment at the Time of the Study
Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Etanercept | 39 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Infliximab | 3 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Adalimumab | 26 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Abatacept | 8 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Tocilizumab | 122 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Rituximab | 8 participants |
| bDMARD Monotherapy | Number of Participants Received Current bDMARD Treatment at the Time of the Study | Certolizumab | 3 participants |
Secondary
Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy
Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy | Corticosteroid + NSAID | 42 participants |
| bDMARD Monotherapy | Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy | Corticosteroids | 39 participants |
| bDMARD Monotherapy | Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy | NSAID | 48 participants |
Secondary
Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment | sDMARD+ bDMARD | 95 participants |
| bDMARD Monotherapy | Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment | bDMARD | 50 participants |
| bDMARD Monotherapy | Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment | sDMARD | 64 participants |
Secondary
Number of Participants Treated With Concomitant Medications Before the Study
Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs \[NSAID\], and other treatment) before the study were presented.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Treated With Concomitant Medications Before the Study | Corticosteroids | 140 participants |
| bDMARD Monotherapy | Number of Participants Treated With Concomitant Medications Before the Study | Non-steroidal anti-inflammatories drugs | 128 participants |
| bDMARD Monotherapy | Number of Participants Treated With Concomitant Medications Before the Study | Other treatment | 19 participants |
Secondary
Number of Participants Who Received Each bDMARD Before the Study
Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Adalimumab | 61 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Abatacept | 10 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Tocilizumab | 4 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Rituximab | 16 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Anakinra | 2 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Etanercept | 58 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Infliximab | 48 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Golimumab | 2 participants |
| bDMARD Monotherapy | Number of Participants Who Received Each bDMARD Before the Study | Certolizumab | 2 participants |
Secondary
Number of Participants Who Received Each sDMARD Before The Study
Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Gold salts | 48 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Chloroquine | 27 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Leflunomide | 130 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Chlorambucil | 1 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Azathioprine | 10 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Penicillamine | 5 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Sulfasalazine | 47 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Hydroxychloroquine | 48 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Ciclosporin | 16 Participants |
| bDMARD Monotherapy | Number of Participants Who Received Each sDMARD Before The Study | Methotrexate | 197 Participants |
Secondary
Number of Participants Who Received Last sDMARD Prescribed Before the Study
Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Azathioprine | 1 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Penicillamine | 1 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Sulfasalazine | 13 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Hydroxychloroquine | 10 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Gold salts | 1 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Leflunomide | 62 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Ciclosporin | 1 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Methotrexate | 119 participants |
| bDMARD Monotherapy | Number of Participants Who Received Last sDMARD Prescribed Before the Study | Leflunomide + methotrexate | 1 participants |
Secondary
Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study
Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study | Tocilizumab | 122 participants |
| bDMARD Monotherapy | Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study | ANTI-TNF | 71 participants |
| bDMARD Monotherapy | Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study | Other | 16 participants |
Secondary
Number of Participants With Adverse Events Leading to a Change of Treatment
An Adverse Event was considered as 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. Adverse events were collected as a reason for the change to monotherapy.
Time frame: At the time of change of treatment
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| bDMARD Monotherapy | Number of Participants With Adverse Events Leading to a Change of Treatment | 96 Participants |
Secondary
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: At the time of change of treatment (to the current treatment)
Population: Analysis population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AEs | 27 Participants |
| bDMARD Monotherapy | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAEs | 07 Participants |
Secondary
Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score
Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | SDAI- Remission/low activity | 84 participants |
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | CDAI- Remission/low activity | 84 participants |
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | SDAI- Moderate/high activity | 38 participants |
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | CDAI- Moderate/high activity | 38 participants |
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | DAS28-Moderate/high activity | 32 participants |
| bDMARD Monotherapy | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | DAS28-Remission/low activity | 90 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | SDAI- Moderate/high activity | 19 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | DAS28-Remission/low activity | 57 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | SDAI- Remission/low activity | 68 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | DAS28-Moderate/high activity | 30 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | CDAI- Remission/low activity | 67 participants |
| Other Treatments | Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score | CDAI- Moderate/high activity | 20 participants |
Secondary
Number of Participants With Changing the Previous sDMARD/ bDMARD
Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | sDMARD, Lack of efficacy, n = 209 | 343 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | sDMARD, Adverse events, n = 209 | 135 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | sDMARD, Intolerance, n = 209 | 25 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | sDMARD, Clinical improvement, n = 209 | 7 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | sDMARD, Other, n = 209 | 40 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | bDMARD, Lack of efficacy, n = 126 | 155 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | bDMARD, Adverse events, n = 126 | 38 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | bDMARD, Intolerance, n = 126 | 5 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | bDMARD, Clinical improvement, n = 126 | 2 Participants |
| bDMARD Monotherapy | Number of Participants With Changing the Previous sDMARD/ bDMARD | bDMARD, Other, n = 126 | 10 Participants |
Secondary
Number of Participants With Reasons for Starting Current Biologic Monotherapy
The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| bDMARD Monotherapy | Number of Participants With Reasons for Starting Current Biologic Monotherapy | Lack of efficacy | 128 participants |
| bDMARD Monotherapy | Number of Participants With Reasons for Starting Current Biologic Monotherapy | Adverse events | 21 participants |
| bDMARD Monotherapy | Number of Participants With Reasons for Starting Current Biologic Monotherapy | Intolerance | 22 participants |
| bDMARD Monotherapy | Number of Participants With Reasons for Starting Current Biologic Monotherapy | Clinical improvement | 22 participants |
| bDMARD Monotherapy | Number of Participants With Reasons for Starting Current Biologic Monotherapy | Other | 16 participants |
Secondary
Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)
Number of sDMARD and bDMARDs received by Participants before the study was presented
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) | Number of sDMARD received before the study, n=209 | 2.63 Number of sDMARD/bDMARD | Standard Deviation 1.36 |
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) | Number of bDMARD received before the study, n=126 | 1.67 Number of sDMARD/bDMARD | Standard Deviation 0.93 |
Secondary
Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)
Time frame: At Visit 1
Population: Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) | No. of sDMARDs tocilizumab before the study,n=122 | 2.59 Number of sDMARD/bDMARDs/Other | Standard Deviation 1.47 |
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) | Other before the study, n=87 | 2.69 Number of sDMARD/bDMARDs/Other | Standard Deviation 1.2 |
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) | bDMARDs-Tocilizumab before the study,n=122 | 1.34 Number of sDMARD/bDMARDs/Other | Standard Deviation 1.1 |
| bDMARD Monotherapy | Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) | bDMARDs-Other before the study, n=87 | 0.53 Number of sDMARD/bDMARDs/Other | Standard Deviation 0.87 |