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This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.
Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
A single participant might be involved in the trial for as many as 32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: All Enrolled Participants | Experimental | All participants receive Acthar Gel 1 mL twice weekly for 12 weeks |
|
| Part 2: Acthar Gel | Experimental | Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks |
|
| Part 2: Placebo | Placebo Comparator | Participants receive Placebo 1 mL twice weekly for an additional 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar Gel | Drug | 80 Units Acthar Gel per 1 mL for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | LDA is defined as DAS28 <3.2. | Baseline to Week 12 |
| Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | Low disease activity is defined as DAS28 <3.2. | Week 12 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Swollen Joint Count by Visit | The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Mallinckrodt Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Rheumatology Medical Group | San Leandro | California | 94578 | United States | ||
| Inland Rheumatology Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32497440 | Derived | Fleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16. | |
| 32185745 | Derived | Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial. Rheumatol Ther. 2020 Jun;7(2):327-344. doi: 10.1007/s40744-020-00199-3. Epub 2020 Mar 17. |
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All participants enrolled in Part 1
A total of 259 patients were recruited at 80 study centers globally for Part 1. Of those participants, 77 were randomized to receive Acthar and 77 were randomized to receive Placebo for an additional 12 weeks, which was Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | All participants who enrolled in the trial |
| FG001 | Part 2: Acthar Gel | Participants receive 1 mL Acthar Gel twice weekly during Part 2, from Week 12 through Week 24 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Open Label |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2016 |
Part 1: Single Group; Part 2: Parallel
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Part 1: Open Label ; Part 2: Double-blind
| Placebo | Drug | Matching placebo 1 mL for subcutaneous injection |
|
|
| Part 2: Swollen Joint Count by Visit During Part 2 | The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28) The DAS28 is a composite score derived from the following assessments:
| Baseline, Week 12 to Week 24 |
| Part 1: Tender Joint Count by Visit | The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| Baseline to Week 12 |
| Part 2: Tender Joint Count by Visit | The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| Baseline, Week 12 to Week 24 |
| Part 1: Patient-Reported General Health by Visit | Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health. | Baseline to Week 12 |
| Part 2: Patient-Reported General Health by Visit | Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health. | Baseline, Week 12 to Week 24 |
| Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments:
| Baseline to Week 12 |
| Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments:
| Baseline, Week 12 to Week 24 |
| Part 1: Patient's Global Assessment of Pain by Visit | Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. | Baseline to Week 12 |
| Part 2: Patient's Global Assessment of Pain by Visit | Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. | Baseline, Week 12 to Week 24 |
| Part 1: Physician's Global Assessment of Disease Activities by Visit | The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. | Baseline to Week 12 |
| Part 2: Physician's Global Assessment of Disease Activities by Visit | The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. | Week 12 to Week 24 |
| Upland |
| California |
| 91786 |
| United States |
| Orthopedic Research Institute | Boynton Beach | Florida | 33472 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Southeastern Integrated Medical, PL, d/b/a Florida Medical Research | Gainesville | Florida | 32607 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Homestead Associates in Research | Homestead | Florida | 33032 | United States |
| Pharmax Research Clinic | Miami | Florida | 33126 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| San Marcus Research Clinic | Miami Lakes | Florida | 33015 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Omega Research Consultants-DeBary | Orlando | Florida | 32810 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Arthritis & Rheumatology of Georgia, PC | Atlanta | Georgia | 30342 | United States |
| Arthritis Research and Treatment Center | Stockbridge | Georgia | 30281 | United States |
| Arthritis and Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | United States |
| June DO, PC | Lansing | Michigan | 48910 | United States |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Columbia Arthritis Center | Columbia | South Carolina | 29204 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Ramesh C. Gupta, MD | Memphis | Tennessee | 38119 | United States |
| Northwest Med Care | Cypress | Texas | 77429 | United States |
| Rheumatic Disease Clinical Research Center | Houston | Texas | 77004 | United States |
| Accurate Clinical Research | Houston | Texas | 77034 | United States |
| Laila Hassan, MD, PA | Houston | Texas | 77089 | United States |
| Pioneer Research Solutions | Houston | Texas | 77099 | United States |
| Southwest Rheumatology Research | Mesquite | Texas | 75150 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Aprillus Asistencia e Investigación | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1046AAQ | Argentina |
| DIM Clínica Privada | Ramos Mejía | Buenos Aires | 1704 | Argentina |
| Centro de Investigaciones Reumatológicas | San Miguel de Tucumán | Tucumán Province | T4000BRD | Argentina |
| Centro Polivalente de Asistencia e Investigación Clínica CER San Juan | San Juan | J5402DIL | Argentina |
| Centro de Investigacion del Noroeste, S.C. | Tijuana | Estado de Baja California | 22010 | Mexico |
| Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara | Jalisco | 44650 | Mexico |
| Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Zapopan | Jalisco | 45030 | Mexico |
| Hospital De Jesus | Mexico City | Mexico City | 06090 | Mexico |
| Consultorio de Reumatología | Mexico City | Mexico City | 07760 | Mexico |
| Consultorio Privado del Dr. Miguel Cortes Hernandez | Cuernavaca | Morelos | 62290 | Mexico |
| Hospital Universitario Dr. José Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Centro de Estudios Clínicos y Especialidades Médicas | Monterrey | Nuevo León | 64620 | Mexico |
| Centro de Alta Especialidad en Reumatologia e Investigación del Potosí | San Luis Potosí City | San Luís Potosí | 78213 | Mexico |
| Centro Especializado en Investigación Clínica | Boca del Río | Veracruz | 94290 | Mexico |
| Centro Peninsular de Investigacion Clinica S.C.P. | Mérida | Yucatán | 97000 | Mexico |
| Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango | 34000 | Mexico |
| Phylasis Clinicas Research S de RL de CV | Estado de México | 54769 | Mexico |
| SMIQ | Querétaro | 76090 | Mexico |
| Centro de Atención e Investigación Cardiovascular del Potosí, S.C. | San Luis Potosí City | 78200 | Mexico |
| INBIOMEDYC Toluca | Toluca | 50130 | Mexico |
| Unidad de Enfermedades Reumaticas y Cronico Degenerativas | Torreón | 27000 | Mexico |
| Clinica Santa Monica | Lima | 15046 | Peru |
| Hospital Nacional Cayetano Heredia | Lima | 15102 | Peru |
| ABK Reuma S.R.L. - Medicentro Biociencias | Pueblo Libre | 15084 | Peru |
| Clinica Vesalio | San Borja | 15036 | Peru |
| Hospital de Apoyo Maria Auxiliadora | San Juán de Miraflores | 15801 | Peru |
| Clínica Médica Cayetano Heredia | San Martín de Porres | 15102 | Peru |
| Mindful Medical Research | San Juan | 00918 | Puerto Rico |
| FG002 | Part 2: Placebo | Participants receive 1 mL placebo twice weekly during Part 2, from Week 12 through Week 24 |
| mITT Population | All participants who received study drug and contributed efficacy data. |
|
| Safety Population | All participants who received study drug. |
|
| Per Protocol Population | All participants who completed the Part 1 of the study without major protocol deviation. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2: Double-blind |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: All Participants Enrolled | All participants who enrolled in the trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | LDA is defined as DAS28 <3.2. | modified Intent to Treat (mITT) Population | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | Low disease activity is defined as DAS28 <3.2. | mITT Population | Posted | Count of Participants | Participants | Week 12 to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Swollen Joint Count by Visit | The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| mITT | Posted | Mean | Standard Deviation | Count of swollen joints | Baseline to Week 12 | Joints | Joints |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Swollen Joint Count by Visit During Part 2 | The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28) The DAS28 is a composite score derived from the following assessments:
| mITT Population | Posted | Mean | Standard Deviation | Count of swollen joints | Baseline, Week 12 to Week 24 | Joints | Joints |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Tender Joint Count by Visit | The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| mITT Population | Posted | Mean | Standard Deviation | Count of Tender Joints | Baseline to Week 12 | Joints | Joints |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Tender Joint Count by Visit | The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments:
| mITT Population | Posted | Mean | Standard Deviation | Count of Tender Joints | Baseline, Week 12 to Week 24 | Joints | Joints |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Patient-Reported General Health by Visit | Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health. | mITT Population | Posted | Mean | Standard Deviation | mm | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Patient-Reported General Health by Visit | Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health. | mITT Population | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments:
| mITT Population | Posted | Mean | Standard Deviation | mm/hr | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments:
| mITT Population | Posted | Mean | Standard Deviation | mm/hr | Baseline, Week 12 to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Patient's Global Assessment of Pain by Visit | Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. | mITT Population | Posted | Mean | Standard Deviation | mm | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Patient's Global Assessment of Pain by Visit | Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. | mITT Population | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Physician's Global Assessment of Disease Activities by Visit | The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. | mITT Population | Posted | Mean | Standard Deviation | mm | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Physician's Global Assessment of Disease Activities by Visit | The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. | mITT Population | Posted | Mean | Standard Deviation | mm | Week 12 to Week 24 |
|
|
Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
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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 | Part 1: All Participants Enrolled | All participants enrolled in the trial with AEs during Part 1 | 0 | 259 | 3 | 259 | 26 | 259 |
| EG001 | Part 2: Placebo | Participants who received Placebo in Part 2 with AEs during Part 2 | 0 | 77 | 0 | 77 | 26 | 77 |
| EG002 | Part 2: Acthar Gel | Participants who received Acthar Gel in Part 2 with AEs during Part 2 | 0 | 77 | 0 | 77 | 22 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | clinicaltrials@mnk.com |
| Mar 6, 2020 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Lost to Follow-up |
|
| Met withdrawal criteria |
|
| Worsening of disease activity |
|
| Did not meet LDA at Week 16 |
|
| Did not meet LDA at Week 20 |
|
| Discontinued exclusion 16 |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| at Week 12 |
|
At Week 8
| Other |
| One-sample binomial test | <0.0001 | Other |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| at Baseline |
| |||||
| at Week 4 |
| |||||
| at Week 8 |
| |||||
| at Week 12 |
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|
|
| Title | Denominators | Categories |
|---|
| at Baseline |
| |||||
| at Week 4 |
| |||||
| at Week 8 |
| |||||
| at Week 12 |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| at Baseline |
| |||||
| at Week 4 |
| |||||
| at Week 8 |
| |||||
| at Week 12 |
|
|