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| ID | Type | Description | Link |
|---|---|---|---|
| P-05121 | Other Identifier | Schering Plough Canada |
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. This type of psoriasis is very difficult to treat as topicals have difficulty penetrating the thick epidermis of palms and soles and are therefore not very effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also usually limited. A number of these patients have very severe hand and feet disease with mild to no involvement elsewhere on the body.
Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if infliximab is safe and if it will improve severity and quality of life in patients with palmoplantar psoriasis, a debilitating variant of psoriasis.
A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a modified palmoplantar pustulosis area severity index (m-PPPASI) of at least 8 will be recruited. Patients will be randomized (1:1) to receive either infliximab 5 mg/kg or placebo (normal saline) on weeks 0, 2 and 6. Patients assigned to placebo during the first 3 infusions will receive infliximab 5 mg/kg at weeks 14, 16 and 20 and placebo again at week 22 while patients who were assigned to receive infliximab during the first 3 infusions will receive infliximab at week 14 and placebo at week 16 and week 20 as well as infliximab for the last infusion at week 22. The primary endpoint will be at week 14. Patients will come back to the clinic at week 26 for a final efficacy and safety assessment.
Efficacy will be evaluated by assessing psoriasis plaque severity on palms and soles (physician's global assessment PGA), percentage of palms and soles area affected by psoriasis (palmoplantar surface area - PPSA) as well as m-PPPASI (modified palmoplantar pustulosis area and severity index). Quality of life will be evaluated at every visit by performing the dermatology life quality index DLQI. Safety will be evaluated by repeating chemistry and haematology laboratories at regular visits as well as by physical examinations and assessment of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then infliximab | Placebo Comparator | Placebo at weeks 0, 2, 6 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. |
|
| Infliximab | Active Comparator | Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0 | Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events at Week 14 | Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events | 14 weeks |
| Mean Dermatology Life Quality Index (DLQI) at Week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Guenther Dermatology Research Center | London | Ontario | N6A 3H7 | Canada | ||
| Lynderm Research Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Infliximab | Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. |
| FG001 | Infliximab | Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention - Day 0 - Week 14 |
| |||||||||||||
| Second Intervention Week 14 - Week 26 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Infliximab | Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. |
| BG001 | Infliximab |
| 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 | 75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0 | Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). | The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward. | Posted | Mar 2010 | Number | Participants | 14 weeks |
|
Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26.
Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
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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 | Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis Right Cheek | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
The lack of validated scales to specifically assess severity of palmoplantar psoriasis. The study was powered to detect a difference of 55 percentage points.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Levesque | Innovaderm Research | 514 521 4285 | 222 | alevesque@innovaderm.ca |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Infliximab | Drug | Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20. |
|
|
Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
| 14 weeks |
| Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14 | Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected). | 14 weeks |
| Mean Physician's Global Assessment (PGA) at Week 14 | Efficacy by comparing the mean Physician's Global Assessment(PGA).
| 14 weeks |
| Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26. m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). | Baseline, 26 weeks |
| Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26. Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
| Baseline, 26 weeks |
| Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.
| Baseline, 26 weeks |
| Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. | Baseline, 26 weeks |
| Markham |
| Ontario |
| L3P 1A8 |
| Canada |
| Innovaderm Research Laval | Laval | Quebec | H7S 2C6 | Canada |
| Innovaderm Research | Montreal | Quebec | H2K 4L5 | Canada |
| Centre de recherche dermatologique du Québec Métropolitain | Québec | Quebec | G1V 4X7 | Canada |
| NOT COMPLETED |
|
|
Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) | m-PPPASI = (E + I + D) Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). | Mean | Standard Deviation | Units on a scale |
|
| Dermatology Life Quality Index (DLQI) | Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
| Mean | Standard Deviation | Units on a scale |
|
| Physician's Global Assessment (PGA) | Efficacy by comparing the mean Physician's Global Assessment(PGA).
| Mean | Standard Deviation | Units on as scale |
|
| Palmoplantar Psoriasis Surface Area PPSA | Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected). | Mean | Standard Deviation | Percentage of affected area |
|
Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
| OG001 | Infliximab | Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. |
|
|
| Secondary | Number of Adverse Events at Week 14 | Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events | Posted | Mar 2010 | Number | Adverse Events | 14 weeks |
|
|
|
| Secondary | Mean Dermatology Life Quality Index (DLQI) at Week 14 | Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
| The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Units on a scale | 14 weeks |
|
|
|
| Secondary | Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14 | Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected). | The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Percentage of affected area | 14 weeks |
|
|
|
| Secondary | Mean Physician's Global Assessment (PGA) at Week 14 | Efficacy by comparing the mean Physician's Global Assessment(PGA).
| The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Units on a scale | 14 weeks |
|
|
|
| Secondary | Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26. m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). | The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Percent improvement | Baseline, 26 weeks |
|
|
|
| Secondary | Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26. Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
| The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Percent improvement | Baseline, 26 weeks |
|
|
|
| Secondary | Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.
| The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Percent improvement | Baseline, 26 weeks |
|
|
|
| Secondary | Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26 | Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. | The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF). | Posted | Mar 2010 | Mean | Standard Deviation | Percent improvement | Baseline, 26 weeks |
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|
| 2 |
| 12 |
| 11 |
| 12 |
| EG001 | Placebo Then Infliximab | Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. | 1 | 12 | 10 | 12 |
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Sternum Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Caused by car accident |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Burn right arm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Burning sensation to feet | Nervous system disorders | Non-systematic Assessment |
|
| Cellulitis Right Elbow | Infections and infestations | Non-systematic Assessment |
|
| Cervical pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Common cold | Infections and infestations | Non-systematic Assessment |
|
| Costal ribs fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Erythema right forearm and both thighs | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial flushing | Vascular disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Feet Oedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ganglion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hair Loss | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Inflammed Seborrheic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Joint pain in hand | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lower legs pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Oesophageal reflux with pyrosis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain following dental surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Pain in foot | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain left shoulder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Paronychia | Infections and infestations | Non-systematic Assessment |
|
| Pruritus right forearm and both thighs | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Swelling left arm | General disorders | Non-systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Vagal reaction | Nervous system disorders | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Vomiting and Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Worsening of asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Worsening of hypertension | Vascular disorders | Non-systematic Assessment |
|
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| D017670 |
| Sodium Compounds |
| 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 |