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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20140412 | Other Identifier | www.ChinaDrugTrials.org |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study will continue to evaluate the safety & efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.
This study (RA0078) will continue to assess the safety, tolerability, and efficacy of Certolizumab Pegol (CZP) for 6 months as additional medication to methotrexate (MTX) with or without folic acid in Chinese subjects with active Rheumatoid Arthritis (RA) who participated in the main feeder study, RA0044. All subjects will continue to receive their established treatment with MTX with or without folic acid. The dose of MTX may be decreased by the Investigator due to toxicity, but should not be discontinued completely. Concomitant nonsteroidal anti-inflammatory drugs and oral corticosteroids will be permitted. For each subject, the study duration will last a maximum of approximately 32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol (CZP) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Drug | Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose. | Baseline to the end of observation period (32 weeks) |
| Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose. | Baseline to the end of observation period (32 weeks) |
| Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) | Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose. | Baseline to the end of observation period (32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline | The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044. |
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Inclusion Criteria:
An Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) for RA0078 is signed and dated by the subject or by the parent(s) or legal representative
Subject/ legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
Subjects must either have:
Subjects must have complied with the protocol requirements during their participation in RA0044
Subjects entering RA0078 who have completed RA0044 must have a clear chest x-ray at the Week 24 Completion Visit of RA0044. Subjects who enter RA0078 at Week 16 of the RA0044 study are not required to have a chest x-ray prior to enrollment
Subject is able to continue treatment with Methotrexate (MTX) (with or without folic acid) at a dose deemed appropriate by the Investigator
Female subjects with childbearing potential should have a negative pregnancy test at Entry and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab pegol (CZP). Medically accepted methods of contraception are: hormonal contraception for at least 2 cycles prior to Screening, intrauterine device, implant device, diaphragm with spermicide, bilateral tubal ligation, monogamous relationship with vasectomized (for at least 3 months prior to Screening) partner, or using condoms with spermicide gel. Abstinence is not an acceptable method of contraception for the study. Female subjects who are postmenopause for at least 2 years or had undergone a complete hysterectomy, bilateral tubal ligation and/ or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential. Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication
Exclusion Criteria:
Rheumatoid Arthritis (RA) disease-related exclusions:
Concomitant medication exclusions
Subjects must be free of the following concomitant medications:
Lactating and/or pregnant female subjects
Male subjects with childbearing potential partner(s) and female subjects of childbearing potential who are NOT practicing effective birth control. All female subjects must test negative on a urine pregnancy test before study entry and at each study visit
Subjects with known TB infection, at high risk of acquiring TB infection, or latent TB (LTB) infection (with exception) are excluded
Subjects who had 3 or more infections requiring systemic antibiotics during RA0044
Subjects with a history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicate an infection (eg, fever, cough)
Subjects with a history or active systemic/ respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria (NTMB)
Radiographic evidence suggestive of any of these infections is sufficient grounds for exclusion
Subjects at a high risk of infection in the Investigator's opinion (eg, subjects with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
Subjects with a known positive hepatitis B surface antigen (HBsAg) test and/ or hepatitis C virus antibody (anti-HCV) test result
Subjects with known human immunodeficiency virus (HIV) infection
Subjects with lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
Subjects with active malignancy of any type
Subjects with a history of blood dyscrasias, eg, leukemia or hemophilia where the blood constituents are abnormal or are present in abnormal quantity.
Subjects with class III or IV congestive heart failure New York Heart Association (NYHA) 1994
Subjects with suspected or diagnosed demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the study. Abnormal laboratory parameters that require exclusion of a subject are detailed in protocol
Subjects with an adverse reaction to Percutaneous Endoscopic Gastrostomy (PEG) or a protein medicinal product or known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 887.822.9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 037 | Baotou | China | ||||
| 001 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Safety Set consisting of all subjects who were dispensed medication.
This study started to enroll subjects in November 2014 and concluded in December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Cimzia (Placebo in Feeder Study) | Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 24 |
| Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline | The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044. | Week 24 |
| Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline | The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044. | Week 24 |
| Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI) | Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline. | Week 24 |
| Beijing |
| China |
| 002 | Beijing | China |
| 013 | Beijing | China |
| 021 | Beijing | China |
| 025 | Beijing | China |
| 033 | Beijing | China |
| 014 | Bengbu | China |
| 034 | Changchun | China |
| 017 | Changsha | China |
| 019 | Changsha | China |
| 007 | Chengdu | China |
| 012 | Chengdu | China |
| 004 | Guangzhou | China |
| 015 | Hangzhou | China |
| 005 | Hefei | China |
| 008 | Heilongjiang | China |
| 011 | Jilin City | China |
| 022 | Jinan | China |
| 031 | Kunming | China |
| 028 | Nanjing | China |
| 009 | Shanghai | China |
| 018 | Shanghai | China |
| 020 | Shanghai | China |
| 030 | Shanghai | China |
| 038 | Shijiazhuang | China |
| 010 | Tianjin | China |
| 006 | Wuhan | China |
| 016 | Xi'an | China |
| 035 | Xi'an | China |
| FG001 | Open-label Cimzia (Cimzia in Feeder Study) | Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set. Demographic baseline refers to RA0044 (NCT02151851) baseline with a subset of subjects who enrolled into RA0078.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Cimzia (Placebo in Feeder Study) | Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. |
| BG001 | Open-label Cimzia (Cimzia in Feeder Study) | Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose. | Safety Set | Posted | Number | percentage of participants | Baseline to the end of observation period (32 weeks) |
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| Primary | Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose. | Safety Set | Posted | Number | percentage of participants | Baseline to the end of observation period (32 weeks) |
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) | Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose. | Safety Set | Posted | Number | percentage of participants | Baseline to the end of observation period (32 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline | The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044. | Safety Set with Non-Responder-Imputation (NRI). | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline | The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044. | Safety Set with Non-Responder-Imputation (NRI). | Posted | Number | percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline | The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044. | Safety Set with Non-Responder-Imputation (NRI). | Posted | Number | percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI) | Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline. | Safety Set with last observation carried forward (LOCF). Only subjects with available data are included in the analysis of this Outcome Measure. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
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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 | Open-label Cimzia (Placebo in Feeder Study) | Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. | 0 | 95 | 6 | 95 | 21 | 95 |
| EG001 | Open-label Cimzia (Cimzia in Feeder Study) | Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. | 0 | 251 | 5 | 251 | 55 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA15.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA15.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA15.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA15.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA15.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA15.1 | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.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 |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
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| Male |
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