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This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab used in line with current clinical practice and local guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis. | At Baseline |
| Baseline Raw DAS28 by Time Since Diagnosis | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis. | At Baseline |
| Baseline Raw DAS28 by Gender | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis. | At Baseline |
| Baseline Raw DAS28 by Country of Residence | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis. | At Baseline |
| Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis. | At Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®).
Subjects will be recruited from approximately 12 countries, including: Austria, Belgium, Denmark, France, Greece, the Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24529163 | Result | Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RA Subjects/ Infliximab 3 mg/kg | Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RA Subjects/ Infliximab 3 mg/kg | Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®). |
| 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 | Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis. | Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline |
|
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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 | Infliximab 3 mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| 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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Blood and Urine samples
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Time since diagnosis | Data available for 703 participants. | Mean | Standard Deviation | years |
|
|
|
|
| Primary | Baseline Raw DAS28 by Time Since Diagnosis | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline |
|
|
|
|
| Primary | Baseline Raw DAS28 by Gender | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis. | Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline |
|
|
|
|
| Primary | Baseline Raw DAS28 by Country of Residence | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline |
|
|
|
|
| Primary | Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis. | All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline |
|
|
|
|
| 40 |
| 721 |
| 0 |
| 721 |
| NAUSEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| HYPERTHERMIA | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| INFUSION RELATED REACTION | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| DISSEMINATED TUBERCULOSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| MASTITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| PNEUMOCYSTIS JIROVECI PNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| PNEUMONIA LEGIONELLA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| SALMONELLOSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| DEVICE FAILURE | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| SYNOVIAL RUPTURE | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| INVESTIGATION | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| OESOPHAGEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| SPEECH DISORDER | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| ALVEOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| JOINT PROSTHESIS USER | Social circumstances | MedDRA 11.1 | Systematic Assessment |
|
| HERNIA REPAIR | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and the sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Mean Baseline DAS28 Raw Score |
| 5.3 |
| Standard Deviation |
| 1.16 |
| 95 |
| 5.0 |
| 5.5 |
| No |
| Superiority or Other |
| Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy) | Mean Baseline DAS28 Raw Score | 5.2 | Standard Deviation | 1.14 | 95 | 5.1 | 5.3 | No | Superiority or Other |
| Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy) | Mean Baseline DAS28 Raw Score | 5.3 | Standard Deviation | 1.16 | 95 | 5.1 | 5.5 | No | Superiority or Other |