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The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab Plus Atacicept | Experimental | Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. |
|
| Rituximab Plus Placebo | Placebo Comparator | Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | Baseline up to Week 64 |
| Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Week 64 | |
| Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. | Baseline, Week 32 |
| Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 | Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. | Baseline, Week 32 |
| Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 | Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32 | ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nice | France | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26137975 | Result | van Vollenhoven RF, Wax S, Li Y, Tak PP. Safety and efficacy of atacicept in combination with rituximab for reducing the signs and symptoms of rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled pilot trial. Arthritis Rheumatol. 2015 Nov;67(11):2828-36. doi: 10.1002/art.39262. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab Plus Atacicept | Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. |
| FG001 | Rituximab Plus Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Atacicept | Drug | Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32. |
|
| Placebo matched to atacicept | Drug | Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32. |
|
| Baseline, Week 32 |
| Week 32 |
| Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 | DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission. | Baseline, Week 32 |
| Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells | Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels. | Baseline, Week 3, 7, 12, 16, 26 and 32 |
| Paris |
| France |
| Research Site | Strasbourg | France |
| Research Site | Amsterdam | Netherlands |
| Research Site | Malmö | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Newcastle | United Kingdom |
| Research Site | Norwich | United Kingdom |
Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab Plus Atacicept | Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. |
| BG001 | Rituximab Plus Placebo | Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | 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 of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | Safety population included all participants who received at least one dose of atacicept or placebo. | Posted | Number | Participants | Baseline up to Week 64 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) | Safety population included all participants who received at least one dose of atacicept or placebo. Here. "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 64 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 | Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. | Safety population included all participants who received at least one dose of atacicept or placebo. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 32 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 | Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. | Safety population included all participants who received at least one dose of atacicept or placebo. Here. "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Week 32 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 | Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value. | Safety population included all participants who received at least one dose of atacicept or placebo. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Week 32 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32 | ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP. | ITT population included all randomized participants. | Posted | Number | percentage of participants | Week 32 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 | DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission. | ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 32 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells | Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels. | Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Week 3, 7, 12, 16, 26 and 32 |
|
|
Baseline up to Week 64
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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 | Rituximab Plus Atacicept | Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. | 6 | 18 | 17 | 18 | ||
| EG001 | Rituximab Plus Placebo | Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32. | 2 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Joint capsule rupture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oropharyngeal blistering | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Benign bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C524618 | TACI receptor-IgG Fc fragment fusion protein |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32. |
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| Units | Counts |
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| Participants |
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