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This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Analysis Set | Participants who received at least one cycle of rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | As prescribed by physician |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| DAS28 Score | The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity. | at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle |
| HAQ Disability Index (HAQ-DI) | The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do). | at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE) | during Cycle 1, during Cycle 2, during the trial (within 12 months) | |
| Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) |
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Inclusion Criteria:
Exclusion Criteria:
Violation of Selection criteria:
Data of patients without approval of data by the physician
Patients without informed consent
Double documentation
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Participants starting treatment with rituximab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 13125 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26517829 | Result | Tony HP, Roll P, Mei HE, Blumner E, Straka A, Gnuegge L, Dorner T; FIRST/ ReFIRST study teams. Combination of B cell biomarkers as independent predictors of response in patients with rheumatoid arthritis treated with rituximab. Clin Exp Rheumatol. 2015 Nov-Dec;33(6):887-94. Epub 2015 Oct 30. |
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Data were recorded throughout Germany in 264 study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Analysis Set | Participants who received at least one cycle of rituximab |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants Who Received One Cycle |
|
| |||||||||||||||||||||||||||
| Subpopulation Who Received Two Cycles |
|
Main analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Analysis Set | Participants who received at least one cycle of rituximab |
| 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 | DAS28 Score | The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity. | Posted | Mean | Standard Deviation | units on a scale | at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle |
|
3 years, 6 months
AEs which cannot be assigned to a Cycle due to missing/incomplete start date are counted in the Total column only
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cycle 1 | During Cycle 1 - Main Analysis Set |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive. |
| 24 weeks after starting Cycle 1 |
| Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) | In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive. | 24 weeks after starting Cycle 2 |
| Death |
|
| Change of therapy |
|
| Severe concomitant disease |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subgroup of seronegative participants |
| OG002 | Seropositive Participants | Subgroup of seropositive participants |
|
|
| Primary | HAQ Disability Index (HAQ-DI) | The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do). | Posted | Mean | Standard Deviation | units on a scale | at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle |
|
|
|
| Secondary | Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE) | Posted | Number | percentage of participants | during Cycle 1, during Cycle 2, during the trial (within 12 months) |
|
|
|
| Secondary | Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) | In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive. | Main Analysis Set with HAQ Score | Posted | Number | participants | 24 weeks after starting Cycle 1 |
|
|
|
| Secondary | Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized) | In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive. | Subpopulation With Two Cycles with HAQ Score | Posted | Number | participants | 24 weeks after starting Cycle 2 |
|
|
|
| 144 |
| 1,653 |
| 0 |
| 1,653 |
| EG001 | Cycle 2 | During Cycle 2 - Subpopulation With Two Cycles | 47 | 820 | 0 | 820 |
| EG002 | Total | During the entire trial | 180 | 1,653 | 0 | 1,653 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA | Systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA | Systematic Assessment |
|
| Drug effect decreased | General disorders | MedDRA | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA | Systematic Assessment |
|
| Hyperplasia | General disorders | MedDRA | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Gallbladder cholesterolosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
|
| Antiphospholipid syndrome | Immune system disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA | Systematic Assessment |
|
| Acute endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cranial nerve infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Encephalitis brain stem | Infections and infestations | MedDRA | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Biopsy prostate | Investigations | MedDRA | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA | Systematic Assessment |
|
| Prostatic acid phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder tamponade | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cystitis glandularis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Breast disorder | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Arterial repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Elbow operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Tendon sheath incision | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Embolism arterial | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| 6 weeks (n=983,0,0) |
|
| 12 weeks (n=1015,116,848) |
|
| 18 weeks (n=784,0,0) |
|
| 24 weeks (n=810,90,681) |
|
| Start 2nd cycle (n=768,68,669) |
|
| 15 days (n=706,67,610) |
|
| 3 months (n=594,59,508) |
|
| 6 months (n=626,56,546) |
|
| Title | Measurements |
|---|---|
|
| Any related TEAE |
|
| Any related serious TEAE |
|
| Any severe TEAE |
|
| Any TEAE leading to discontinuation |
|
| Any TEAE leading to death |
|
|
| Subgroup 3: Anti-CCP+/RF- (n=45) |
|
| Subgroup 4: Anti-CCP+/RF+ (n=375) |
|
| Subgroup 5: Anti-CCP n.sp./RF+ (n=109) |
|
| Subgroup 6: Anti-CCP n.sp./RF- (n=29) |
|
| Subgroup 7: Anti-CCP+/RF n.sp. (n=19) |
|
| Subgroup 8: Anti-CCP-/RF n.sp. (n=2) |
|
| Subgroup 9: Seropositive n.sp. (n=17) |
|
| Subgroup 10: Anti-CCP and RF n.sp. (n=36) |
|
| Subgroup 1+6+8: seronegative (n=75) |
|
| Subgroup 2+3+4+5+7+9: seropositive (n=584) |
|
|
| Subgroup 3: Anti-CCP+/RF- (n=36) |
|
| Subgroup 4: Anti-CCP+/RF+ (n=314) |
|
| Subgroup 5: Anti-CCP n.sp./RF+ (n=100) |
|
| Subgroup 6: Anti-CCP n.sp./RF- (n=17) |
|
| Subgroup 7: Anti-CCP+/RF n.sp. (n=14) |
|
| Subgroup 8: Anti-CCP-/RF n.sp. (n=2) |
|
| Subgroup 9: Seropositive n.sp. (n=10) |
|
| Subgroup 10: Anti-CCP and RF n.sp. (n=22) |
|
| Subgroup 1+6+8: seronegative (n=52) |
|
| Subgroup 2+3+4+5+7+9: seropositive (n=485) |
|