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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135IIM2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-505314-20-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipocalimab | Experimental | Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106. |
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| Placebo | Placebo Comparator | Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered intravenously in double-blind period and LTE period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 | Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS at Week 52 and on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as IMACS TIS greater than or equal to (>=) 20 in participants with IIM. The criteria use the 6 IMACS core set measures: physicians' global activity, patient global activity (PtGA), manual muscle testing (MMT)-8, muscle enzymes, myositis disease activity assessment tool (MDAAT), and health assessment questionnaire-disability index (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis and Rheumatology Research PLLC | Phoenix | Arizona | 85032 | United States | ||
| HonorHealth Neurology |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Other | Nipocalimab matching placebo will be administered intravenously in double-blind period. |
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| Glucocorticoids | Drug | Prednisone or equivalent will be administered orally as Glucocorticoid. |
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| At Week 24 |
| IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Week 52 |
| Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Moderate improvement is defined as IMACS TIS >=40 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Week 24 |
| Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52 | Change from baseline in MMT-8 score at Week 52 will be reported. Manual muscle testing is a partially validated tool to assess muscle strength. It evaluates 8 muscle groups containing 1 axial, 5 proximal, and 2 distal muscle groups. MMT-8 score ranges from 0-150. Higher score indicates greater muscle strength, that is, less impairment of muscle. | Baseline and Week 52 |
| IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Week 24 |
| Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Moderate improvement is defined as IMACS TIS >=40 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Week 52 |
| Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Major improvement is defined as IMACS TIS >=60 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | At Weeks 24 and 52 |
| Change From Baseline in MMT-8 at Week 24 | Change from baseline in MMT-8 score at Week 24 will be reported. Manual Muscle Testing is a partially validated tool to assess muscle strength. It evaluates 8 muscle groups containing 1 axial, 5 proximal, and 2 distal muscle groups. MMT-8 score ranges from 0-150. Higher score indicates greater muscle strength, that is, less impairment of muscle. | Baseline and Week 24 |
| Change From Baseline in Physician Global Assessment (PhGA) at Weeks 24 and Week 52 | Change from baseline in PhGA at Weeks 24 and 52 will be reported. Physician Global Activity is a partially validated tool to measure the global evaluation by the physician of the participant's overall disease activity at the time of assessment using a 10 centimeter (cm) visual analogue scale (VAS), where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity. | Baseline, Weeks 24 and 52 |
| Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52 | Change from baseline in MDAAT score at Weeks 24 and 52 will be reported. This is a validated tool which measures the degree of disease activity of extramuscular organ systems and muscle. MDAAT is scored on a 10 centimeter (cm) scale ranging from 0-10 cm where, 0 cm = absent and 10 cm = maximum disease activity. Higher score indicates more disease activity. | Baseline, Weeks 24 and 52 |
| Change From Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52 | Change from baseline in serum muscle enzymes levels (creatine kinase [CK], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactate dehydrogenase [LDH], and aldolase) at Weeks 24 and 52 will be reported. | Baseline, Weeks 24 and 52 |
| Percentage of Participants who Achieve Oral Glucocorticoids (GC) Reduction to 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent), Among Participants on Oral GC Greater Than (>) 5 mg/day at Baseline | Percentage of participants who achieve oral GC reduction to 5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >5 mg/day at baseline will be reported. | From Week 44 through Week 52 |
| Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on Less Than or Equal to (<=) 5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 | Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | From Week 44 through Week 52 |
| Percentage of Participants on <=5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 | Percentage of participants on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. | From Week 44 through Week 52 |
| Percentage of Participants who Achieve At Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to 5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >5 mg/day at Baseline | Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and achieve oral GC reduction to 5 mg/day of prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >5 mg/day at baseline will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | From Week 44 through Week 52 |
| Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on <=7.5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 | Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and on <=7.5 mg/day of Oral Prednisone (or Equivalent) from Week 44 through Week 52 will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | From Week 44 through Week 52 |
| Percentage of Participants who Achieve Oral GC Reduction to <=7.5 mg/day of Oral Prednisone (or Equivalent) at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline | Percentage of participants who achieve oral GC reduction to <=7.5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >7.5 mg/day at baseline will be reported. | At Week 44 through Week 52 |
| Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to <=7.5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline | Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and achieve oral GC reduction to <=7.5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >7.5 mg/day at Baseline will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | From Week 44 through Week 52 |
| IMACS TIS Over Time | IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement. | Up to 106 weeks |
| Change From Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52 | The CDASI scale is a validated dermatomyositis (DM) specific instrument that systematically quantifies activity and damage in the skin of participant with DM. Disease involvement in 15 different anatomical locations is rated using three activity scales (erythema, scale, erosion/ulceration) and two damage measures (poikiloderma, calcinosis) measures. Gottron's papules/sign on the hands are also evaluated in terms of activity (erythema/ulceration) and damage (dyspigmentation or scarring). Disease activity scores range from 0 to 100. Higher scores indicate greater disease activity. | Baseline, Weeks 24 and 52 |
| Change in CDASI Scale Score Over Time | The CDASI scale is a validated DM specific instrument that systematically quantifies activity and damage in the skin of participant with DM. Disease involvement in 15 different anatomical locations is rated using three activity scales (erythema, scale, erosion/ulceration) and two damage measures (poikiloderma, calcinosis) measures. Gottron's papules/sign on the hands are also evaluated in terms of activity (erythema/ulceration) and damage (dyspigmentation or scarring). Disease activity scores range from 0 to 100. Higher scores indicate greater disease activity. | Up to 106 Weeks |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) | Any AE occurring at or after the initial administration of study intervention through the safety follow-up visit will be considered as treatment-emergent. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. | Up to 106 weeks |
| Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Any AE occurring at or after the initial administration of study intervention through the safety follow-up visit will be considered as treatment-emergent. An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. | Up to 106 weeks |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20 | PROMIS-PF-20 is a participant self-administered 20-item questionnaire assessing the physical function domain. It includes 14 items regarding patients' ability to conduct specific functional activities and 6 items regarding the extent to which their health limits their ability to perform a range of physical activities currently. The 5-point response options for the former items range from 1 "Unable to do" to 5 "Without any difficulty" and the latter items range from 1 "Cannot do" to 5 "Not at all" with higher scores indicating better functioning. The overall score ranges from 0 to 100, where higher score indicates better physical function. | Baseline and Week 52 |
| Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI) | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of functional disability a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and common activities of daily living). Responses in each functional area are scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. | Baseline, Weeks 24 and 52 |
| Serum Nipocalimab Concentration Over Time | Serum nipocalimab concentration over time will be reported. Serum nipocalimab concentration will be derived using population pharmacokinetic (PK) modeling. | Baseline Up to Week 98 |
| Number of Participants With Anti-drug Antibody (ADA) Measured Using a Validated, Specific, and Sensitive Immunoassay Method | Number of participants with ADA to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported. | Baseline Up to Week 106 |
| Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method | Number of participants with Nabs to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported. | Baseline Up to Week 106 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Attune Health Autoimmune and Inflamation Care and Research | Beverly Hills | California | 90211 | United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| FM Clinical Research, LLC South Florida Neurology Associates, P. A. | Boca Raton | Florida | 33487 | United States |
| Integral Rheumatology And Immunology Specialists | Plantation | Florida | 33324 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| The Brigham and Women's Hospital, Inc. | Boston | Massachusetts | 02115 | United States |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | 48081 | United States |
| Wexner Medical Center at the Ohio State University | Columbus | Ohio | 43203 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| ACME Research Arthritis and Osteoporosis Center | Orangeburg | South Carolina | 29118 | United States |
| Nervie and Muscle Center of Texas | Houston | Texas | 77030 | United States |
| University of Texas at Houston Medical School | Houston | Texas | 77030 | United States |
| Lawson Health Research / London Health Sciences Center Research | London | Ontario | N6C 2R5 | Canada |
| AMIR Research | Montreal | Quebec | H4A 3T2 | Canada |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Hospital Pasteur | Nice | 06000 | France |
| Hopital Pitie Salpetriere | Paris | 75013 | France |
| Nouvel Hopital Civil | Strasbourg | 67091 | France |
| Charite Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Klinikum der Universitaet Muenchen | München | 80336 | Germany |
| Immanuel Klinik Rudersdorf | Rüdersdorf Bei Berlin | 15562 | Germany |
| Orszagos Mozgasszervi Intezet ORFI Campus | Budapest | 1023 | Hungary |
| Debreceni Egyetem | Debrecen | 4032 | Hungary |
| A.O. Universitaria Ospedali Riuniti di Ancona | Ancona | 60126 | Italy |
| IRCSS Ospedale San Raffaele Turro | Milan | 20127 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Roma | 00168 | Italy |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810 8563 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960 1295 | Japan |
| St Marianna University Hospital | Kanagawa | 216 8511 | Japan |
| National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano | 586 8521 | Japan |
| Tokushukai Chiba-Nishi General Hospital | Matsudo-shi | 270-2251 | Japan |
| Shinshu University Hospital | Matsumoto | 390-8621 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| St. Luke's International Hospital | Tokyo | 104 8560 | Japan |
| Nippon Medical School Hospital | Tokyo | 113 8603 | Japan |
| Centro Integral en Reumatologia S A de C V | Guadalajara | 44160 | Mexico |
| Centro de Estudios de Investigacion Basica y Clinica, S.C. | Guadalajara | 44690 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | 14080 | Mexico |
| CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V | México | 06700 | Mexico |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85 168 | Poland |
| Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warsaw | 02 637 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Hosp. Univ. de Bellvitge | Barcelona | 08907 | Spain |
| Hosp. Univ. de La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| University College London Hospitals NHSFT | London | WC1N 3BG | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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