Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Terminated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.
This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remsima™ | Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group. | ||
| Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. | ||
| Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group. | ||
| Remicade | Patients who have received only Remicade or switched from non-biologic treatment to Remsima were included in this analysis group. | ||
| Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | ||
| Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. | ||
| Other Anti-TNF |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI) |
| Duration of study participation (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP) | Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96 Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm) Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 < 2.6 Low Disease Activity: 2.6 ≤ DAS28 < 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 < DAS28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klara Sirova | Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34250583 | Derived | Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12. |
Not provided
Not provided
A total of 302 patients were screened, and 248 patients were enrolled.
Participant flow was summarized by all analysis groups as prespecified in Statistical Analysis Plan.
According to study protocol inclusion criteria, without prior RA medication restrictions, patients who received Remsima, Remicade, Other anti-TNF and biologic naïve were enrolled and switching between were allowed
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Remsima | Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group. |
| FG001 | Switch to Remsima | Patients who switched from Remicade to Remsima were included in this analysis group. |
| FG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group. |
| FG003 | Remicade | Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group. |
| FG004 | Switch to Remicade | Patients who switched from Remsima to Remicade were included in this analysis group. |
| FG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. |
| FG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
|
| FG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group. |
| FG008 | Biologic Naïve | Patients who received only non-biologic treatment will be included in this analysis group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remsima | Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group. |
| BG001 | Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI) |
| The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used. All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups. | Posted | Count of Participants | Participants | Duration of study participation (up to 5 years) |
Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remsima | Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc | 82-32-850-5702 | jiwoong.lim@celltrion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2015 | Aug 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2020 | Aug 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Following patients were included in other anti-TNF group.
| Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group |
| Biologic Naïve | Patients who received only non-biologic treatment will be included in this analysis group |
| Day 0 ~ Week 198 (every 6 months ±6 weeks) |
| Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability | The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability. There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3. Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability. | Day 0 ~ Week 198 (every 6 months ±6 weeks) |
| Disease Progression |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Study Close |
|
| except for study close |
|
| BG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group |
| BG003 | Remicade | Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group. |
| BG004 | Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. |
| BG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. |
| BG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
|
| BG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group. |
| BG008 | Biologic Naïve | Patients who received only non-biologic treatment will be included in this analysis group. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP) | Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96 Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm) Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 < 2.6 Low Disease Activity: 2.6 ≤ DAS28 < 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 < DAS28 | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Week 198 (every 6 months ±6 weeks) |
|
|
|
| Secondary | Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability | The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability. There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3. Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability. | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Week 198 (every 6 months ±6 weeks) |
|
|
|
| 0 |
| 111 |
| 16 |
| 111 |
| 56 |
| 111 |
| EG001 | Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. | 0 | 8 | 2 | 8 | 6 | 8 |
| EG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group. | 0 | 15 | 4 | 15 | 7 | 15 |
| EG003 | Remicade | Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG004 | Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
| 0 | 81 | 11 | 81 | 39 | 81 |
| EG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG008 | Biologic Naïve | Patients who received only non-biologic treatment will be included in this analysis group. | 0 | 23 | 2 | 23 | 13 | 23 |
| Prinzmetal angina | Cardiac disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | Systematic Assessment |
|
| Otitis Media | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Facial Bones Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Urticarial vasculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatic Cyst | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatitis Acute | Hepatobiliary disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | Systematic Assessment |
|
| Latent Tuberculosis | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Tinea Pedis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Lactation Disorder | Reproductive system and breast disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Swelling face | General disorders | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Localized Infection | Infections and infestations | Systematic Assessment |
|
| Otitis externa | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Liver function test increased | Investigations | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scleroderma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | Systematic Assessment |
|
| Menopausal disorder | Reproductive system and breast disorders | Systematic Assessment |
|
| Dydspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Week 30 DAS28 (ESR) |
|
|
| Week 54 DAS28 (ESR) |
|
|
| Week 78 DAS28 (ESR) |
|
|
| Week 102 DAS28 (ESR) |
|
|
| Week 126 DAS28 (ESR) |
|
|
| Week 150 DAS28 (ESR) |
|
|
| Week 174 DAS28 (ESR) |
|
|
| Week 198 DAS28 (ESR) |
|
|
| Day 0 DAS28 (CRP) |
|
|
| Week 30 DAS28 (CRP) |
|
|
| Week 54 DAS28 (CRP) |
|
|
| Week 78 DAS28 (CRP) |
|
|
| Week 102 DAS28 (CRP) |
|
|
| Week 126 DAS28 (CRP) |
|
|
| Week 150 DAS28 (CRP) |
|
|
| Week 174 DAS28 (CRP) |
|
|
| Week 198 DAS28 (CRP) |
|
|
|
| Week 30 HAQ |
|
|
| Week 54 HAQ |
|
|
| Week 78 HAQ |
|
|
| Week 102 HAQ |
|
|
| Week 126 HAQ |
|
|
| Week 150 HAQ |
|
|
| Week 174 HAQ |
|
|
| Week 198 HAQ |
|
|