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Terminated
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An observational, prospective cohort study to evaluate the safety and efficacy of Remsimaâ„¢ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)
This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of Remsimaâ„¢ in patients with IBD, who have active Crohn's disease (CD), fistulizing Crohn's disease (CD), or Ulcerative Colitis (UC). Patients will be included in this registry who are receiving treatment with 5 mg/kg of Remsimaâ„¢ by IV infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. If a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remsimaâ„¢ | Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. | ||
| Switched to Remsima | Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Including Hepatitis B virus (HBV) reactivation, congestive heart failure, opportunistic infections (excluding tuberculosis), serious infections including sepsis (excluding opportunistic infections and tuberculosis), tuberculosis (TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, lymphoma (not hepatosplenic T cell lymphoma), hepatobiliary events, hepatosplenic T cell lymphoma, intestinal or perianal abscess (in Crohn's disease), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy (excluding lymphoma), colon carcinoma/dysplasia (in Ulcerative Colitis), skin cancer, pregnancy exposure, bowel stenosis/stricture/obstruction (in Crohn's disease) and infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction. | Up to 5 years for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 | A patient is considered as achieving clinical response according to CDAI-70 (or CDAI-100) if the patient has a reduction on CDAI score of 70 (or 100) points or more from the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of at least 500 male and female patients with active CD, fistulizing active CD, and UC
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Svoboda | Ostrava, Morvskoslezsky kraj, Czech Republic, 708 52 | Principal Investigator |
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| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remsima (CT-P13) | Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. |
| FG001 | Switched to Remsima (CT-P13) | Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set, consist of all patients who received at least one dose of the study treatment during any dosing period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Remsima (CT-P13) | Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. |
| BG001 | Switched to Remsima (CT-P13) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Including Hepatitis B virus (HBV) reactivation, congestive heart failure, opportunistic infections (excluding tuberculosis), serious infections including sepsis (excluding opportunistic infections and tuberculosis), tuberculosis (TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, lymphoma (not hepatosplenic T cell lymphoma), hepatobiliary events, hepatosplenic T cell lymphoma, intestinal or perianal abscess (in Crohn's disease), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy (excluding lymphoma), colon carcinoma/dysplasia (in Ulcerative Colitis), skin cancer, pregnancy exposure, bowel stenosis/stricture/obstruction (in Crohn's disease) and infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction. | Safety analysis set, all patients who received at least one dose of study treatment. Intestinal or perianal abscess and bowel stenosis/stricture/obstruction events are only applicable for patients with moderate to severe active CD, fistulising active CD and paediatric severe active CD. Colon carcinoma/dysplasia is only applicable for patients with moderate to severe active UC and paediatric severe active UC. Paediatric malignancy is only applicable for paediatric patients. | Posted | Count of Participants | Participants |
Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
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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 | Remsima (CT-P13) | Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc | 82-32-850-5702 | jiwoong.lim@celltrion.com |
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| 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 |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Every 6 months (months 6 -60) |
| Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 | A patient is considered as achieving clinical response according to PCDAI if the patient has a PCDAI score less than or equal to 30 points and a reduction on PCDAI score of 15 points or more from the baseline value. | Every 6 months (months 6 -42) |
| Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline | A patient is considered as achieving clinical response according to the number of draining fistulas if the patient has a reduction on the number of draining fistulas from the baseline value (over a period of ≥ 4 weeks) ≥ 50%. | Every 6 months (months 6 -48) |
| Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. | A patient is considered as achieving clinical response according to total Mayo score if the patient has a reduction from baseline in total mayo score at least 3 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. A patient is considered as achieving clinical response according to partial Mayo score if the patient has a reduction from baseline in partial mayo score at least 2 points, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. | Every 6 months (months 6 - 60) |
| Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | A patient is considered as achieving clinical response according to PUCAI if the patient has a reduction on PUCAI score of 20 points or more from the baseline value. | Every 6 months (months 6 - 18) |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Disease progression |
|
| Study close |
|
| except for study close |
|
Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Up to 5 years for each patient |
|
|
|
| Secondary | Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 | A patient is considered as achieving clinical response according to CDAI-70 (or CDAI-100) if the patient has a reduction on CDAI score of 70 (or 100) points or more from the baseline value. | Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit. | Posted | Count of Participants | Participants | Every 6 months (months 6 -60) |
|
|
|
| Secondary | Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 | A patient is considered as achieving clinical response according to PCDAI if the patient has a PCDAI score less than or equal to 30 points and a reduction on PCDAI score of 15 points or more from the baseline value. | Efficacy analysis set, consist of all Pediatric severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline. | Posted | Count of Participants | Participants | Every 6 months (months 6 -42) |
|
|
|
| Secondary | Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline | A patient is considered as achieving clinical response according to the number of draining fistulas if the patient has a reduction on the number of draining fistulas from the baseline value (over a period of ≥ 4 weeks) ≥ 50%. | Efficacy analysis set, consist of all Fistulizing Active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline. | Posted | Count of Participants | Participants | Every 6 months (months 6 -48) |
|
|
|
| Secondary | Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. | A patient is considered as achieving clinical response according to total Mayo score if the patient has a reduction from baseline in total mayo score at least 3 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. A patient is considered as achieving clinical response according to partial Mayo score if the patient has a reduction from baseline in partial mayo score at least 2 points, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. | Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit. | Posted | Count of Participants | Participants | Every 6 months (months 6 - 60) |
|
|
|
| Secondary | Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | A patient is considered as achieving clinical response according to PUCAI if the patient has a reduction on PUCAI score of 20 points or more from the baseline value. | Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit. | Posted | Count of Participants | Participants | Every 6 months (months 6 - 18) |
|
|
|
| 5 |
| 407 |
| 53 |
| 407 |
| 221 |
| 407 |
| EG001 | Switched to Remsima (CT-P13) | Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter. | 0 | 63 | 10 | 63 | 34 | 63 |
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Large intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
|
| Generalised Oedema | General disorders | Systematic Assessment |
|
| Localised Oedema | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | Systematic Assessment |
|
| Anal abscess | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Chronic Hepatitis B | Infections and infestations | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
|
| Rotavirus infection | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| High risk pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Threatened labour | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | Systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Seborrheic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | Systematic Assessment |
|
| Anal skin tags | Gastrointestinal disorders | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Cheilosis | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophagel reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Hypertransaminaesaemia | Hepatobiliary disorders | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Oral herpes | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Varicella zoster virus infection | Infections and infestations | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bone density decreased | Investigations | Systematic Assessment |
|
| Faecal calprotectin increased | Investigations | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| Clinical response according to CDAI-70 at 12 months |
|
|
| Clinical response according to CDAI-70 at 18 months |
|
|
| Clinical response according to CDAI-70 at 24 months |
|
|
| Clinical response according to CDAI-70 at 30 months |
|
|
| Clinical response according to CDAI-70 at 36 months |
|
|
| Clinical response according to CDAI-70 at 42 months |
|
|
| Clinical response according to CDAI-70 at 54 months |
|
|
| Clinical response according to CDAI-70 at 48 months |
|
|
| Clinical response according to CDAI-70 at 60 months |
|
|
| Clinical response according to CDAI-100 at 6 months |
|
|
| Clinical response according to CDAI-100 at 12 months |
|
|
| Clinical response according to CDAI-100 at 18 months |
|
|
| Clinical response according to CDAI-100 at 24 months |
|
|
| Clinical response according to CDAI-100 at 30 months |
|
|
| Clinical response according to CDAI-100 at 36 months |
|
|
| Clinical response according to CDAI-100 at 42 months |
|
|
| Clinical response according to CDAI-100 at 48 months |
|
|
| Clinical response according to CDAI-100 at 54 months |
|
|
| Clinical response according to CDAI-100 at 60 months |
|
|
| Clinical response at 12 months |
|
|
| Clinical response at 18 months |
|
|
| Clinical response at 24 months |
|
|
| Clinical response at 30 months |
|
|
| Clinical response at 36 months |
|
|
| Clinical response at 42 months |
|
|
| Clinical response at 12 months |
|
|
| Clinical response at 18 months |
|
|
| Clinical response at 24 months |
|
|
| Clinical response at 30 months |
|
|
| Clinical response at 36 months |
|
|
| Clinical response at 42 months |
|
|
| Clinical response at 48 months |
|
|
| Clinical response according to total mayo score at 12 months |
|
|
| Clinical response according to total mayo score at 18 months |
|
|
| Clinical response according to total mayo score at 24 months |
|
|
| Clinical response according to total mayo score at 30 months |
|
|
| Clinical response according to total mayo score at 36 months |
|
|
| Clinical response according to total mayo score at 42 months |
|
|
| Clinical response according to total mayo score at 48 months |
|
|
| Clinical response according to total mayo score at 54 months |
|
|
| Clinical response according to total mayo score at 60 months |
|
|
| Clinical response according to partial mayo score at 6 months |
|
|
| Clinical response according to partial mayo score at 12 months |
|
|
| Clinical response according to partial mayo score at 18 months |
|
|
| Clinical response according to partial mayo score at 24 months |
|
|
| Clinical response according to partial mayo score at 30 months |
|
|
| Clinical response according to partial mayo score at 36 months |
|
|
| Clinical response according to partial mayo score at 42 months |
|
|
| Clinical response according to partial mayo score at 48 months |
|
|
| Clinical response according to partial mayo score at 54 months |
|
|
| Clinical response according to partial mayo score at 60 months |
|
|
| Clinical response at 12 months |
|
|
| Clinical response at 18 months |
|
|