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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
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This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
The study population was chosen from a non-probability sample.
The safety population consisted of all participants with at least one documented infusion of infliximab.
The evaluable population consisted of all participants that were >=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing at Least One Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event. | Baseline to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinicians' Impression of Disease Severity From Baseline to Week 102 | Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Of 4485 total enrolled participants, 4465 received at least one infusion of infliximab and are included in the safety evaluation. 3228 of these participants were evaluable for all other study analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Experiencing at Least One Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event. | The safety evaluable population consisted of all participants with that received at least one infusion of infliximab. | Posted | Number | Participants | Baseline to Month 24 |
|
Not provided
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
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 | Infliximab | Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@Merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 |
| Clinicians' Impression of Therapeutic Efficacy | Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit. | Week 6, Week 14, Week 22, Week 54, Week 102 |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
|
| Secondary | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit. | The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks. | Posted | Number | Percentage of Participants | Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 |
|
|
|
| Secondary | Clinicians' Impression of Therapeutic Efficacy | Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit. | The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks. | Posted | Number | Percentage of Participants | Week 6, Week 14, Week 22, Week 54, Week 102 |
|
|
|
| 296 |
| 4,465 |
| 0 |
| 4,465 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cadiovascular disorder | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Blindness transient | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Eyelid Oedema | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Parathesia oral | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sense of oppression | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anaphylactic reactions | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Antinuclear antibody increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood pressure | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood pressure orthostatic | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| DNA antibody positive | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Systemic lupus erythematosus disease activity index abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Nasal cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Nodular fasciitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Parathesia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pruritis generalised | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Uticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abscess drainage | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Bursa removal | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Elbow operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Polypectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Proctocolectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Rheumatoid nodule removal | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Sigmoidectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Thyroid operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Baseline - Moderately ill |
|
| Baseline - Markedly ill |
|
| Baseline - Severely ill |
|
| Baseline - Extreme severe illness |
|
| Week 6 - Not at all ill |
|
| Week 6 - Borderline ill |
|
| Week 6 - Mildly ill |
|
| Week 6 - Moderately ill |
|
| Week 6 - Markedly ill |
|
| Week 6 - Severely ill |
|
| Week 6 - Extreme severe illness |
|
| Week 14 - Not at all ill |
|
| Week 14 - Borderline ill |
|
| Week 14 - Mildly ill |
|
| Week 14 - Moderately ill |
|
| Week 14 - Markedly ill |
|
| Week 14 - Severely ill |
|
| Week 14 - Extreme severe illness |
|
| Week 22 - Not at all ill |
|
| Week 22 - Borderline ill |
|
| Week 22 - Mildly ill |
|
| Week 22 - Moderately ill |
|
| Week 22 - Markedly ill |
|
| Week 22 - Severely ill |
|
| Week 22 - Extreme severe illness |
|
| Week 54 - Not at all ill |
|
| Week 54 - Borderline ill |
|
| Week 54 - Mildly ill |
|
| Week 54 - Moderately ill |
|
| Week 54 - Markedly ill |
|
| Week 54 - Severely ill |
|
| Week 54 - Extreme severe illness |
|
| Week 102 - Not at all ill |
|
| Week 102 - Borderline ill |
|
| Week 102 - Mildly ill |
|
| Week 102 - Moderately ill |
|
| Week 102 - Markedly ill |
|
| Week 102 - Severely ill |
|
| Week 102 - Extreme severe illness |
|
| Title | Measurements |
|---|---|
|
| Week 6: Mild-to-Slight Improvement |
|
| Week 6: Very Good-to-Full Improvement |
|
| Week 6: Worsened |
|
| Week 14: Moderate-to-Clear Improvement |
|
| Week 14: Unchanged |
|
| Week 14: Not Assessable |
|
| Week 14: Mild-to-Slight Improvement |
|
| Week 14: Very Good-to Full Improvement |
|
| Week 14: Worsened |
|
| Week 22: Moderate-to-Clear Improvement |
|
| Week 22: Unchanged |
|
| Week 22: Not Assessable |
|
| Week 22: Mild-to-Slight Improvement |
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| Week 22: Very Good-to-Full Improvement |
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| Week 22: Worsened |
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| Week 54: Moderate-to-Clear Improvement |
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| Week 54: Unchanged |
|
| Week 54: Not Assessable |
|
| Week 54: Mild-to-Slight Improvement |
|
| Week 54: Very Good-to-Full Improvement |
|
| Week 54: Worsened |
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| Week 102: Moderate-to-Clear Improvement |
|
| Week 102: Unchanged |
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| Week 102: Not Assessable |
|
| Week 102: Mild-to-Slight Improvement |
|
| Week 102: Very Good-to-Full Improvement |
|
| Week 102: Worsened |
|