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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003053-21 | EudraCT Number |
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This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period.
In the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.
At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-3373 Followed by Placebo | Experimental | Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22. |
|
| Adalimumab | Experimental | Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-3373 | Drug | ABBV-3373 is administered as intravenous (IV) infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI) | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheum Assoc of North Alabama /ID# 213626 | Huntsville | Alabama | 35801 | United States | ||
| AZ Arthritis and Rheum Researc /ID# 208515 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36512671 | Derived | Buttgereit F, Aelion J, Rojkovich B, Zubrzycka-Sienkiewicz A, Chen S, Yang Y, Arikan D, D'Cunha R, Pang Y, Kupper H, Radstake T, Amital H. Efficacy and Safety of ABBV-3373, a Novel Anti-Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody-Drug Conjugate, in Adults with Moderate-to-Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double-Blind, Active-Controlled Proof-of-Concept Phase IIa Trial. Arthritis Rheumatol. 2023 Jun;75(6):879-889. doi: 10.1002/art.42415. Epub 2023 Apr 2. |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants were randomly assigned in a 2:1 ratio to either ABBV-3373 or adalimumab. Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/d prednisone equivalent) for treatment of RA at Baseline (yes/no) and prior exposure to non-anti-tumor necrosis factor (TNF) biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for less than 3 months and terminated not due to lack of efficacy or intolerance (yes/no).
Participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) were enrolled at 14 sites in the United States and Puerto Rico, Poland, Hungary, and Israel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants were administered placebo to ABBV-3373 by intravenous (IV) infusion and 80 mg adalimumab by subcutaneous injection every other week (EOW) for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22. |
| FG001 | ABBV-3373 Followed by Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Week 1 to Week 12 |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2020 | Jun 29, 2021 |
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| Placebo for ABBV-3373 |
| Drug |
Placebo for ABBV-3373 is administered as IV infusion |
|
| Adalimumab | Drug | Adalimumab is administered as subcutaneous (SC) injection |
|
|
| Placebo for adalimumab | Drug | Placebo for adalimumab is administered as subcutaneous (SC) injection |
|
| Baseline and Week 12 |
| Change From Baseline in Simplified Disease Activity Index (SDAI) | The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Baseline and Week 12 |
| Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR]) | The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity. | Baseline and Week 12 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity. | Week 12 |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Baseline and Week 12 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| C.V. Mehta MD, Med Corporation /ID# 213068 | Hemet | California | 92543 | United States |
| Robin K. Dore MD, Inc /ID# 213045 | Tustin | California | 92780 | United States |
| Inland Rheum & Osteo Med Grp /ID# 213044 | Upland | California | 91786 | United States |
| Suncoast Clinical Research /ID# 213973 | New Port Richey | Florida | 34652 | United States |
| Arthritis Center, Inc. /ID# 213972 | Palm Harbor | Florida | 34684 | United States |
| W. Broward Rheum Assoc Inc. /ID# 211017 | Tamarac | Florida | 33321 | United States |
| BayCare Medical Group, Inc. /ID# 213935 | Tampa | Florida | 33614-7101 | United States |
| Institute of Arthritis Researc /ID# 213043 | Idaho Falls | Idaho | 83404 | United States |
| PRN Professional Research Network of Kansas, LLC /ID# 213046 | Wichita | Kansas | 67205 | United States |
| Clinvest Research LLC /ID# 215451 | Springfield | Missouri | 65810-2607 | United States |
| Duke Early Phase Research Unit (DCRI) /ID# 213212 | Durham | North Carolina | 27710 | United States |
| Paramount Medical Research Con /ID# 209042 | Middleburg Heights | Ohio | 44130 | United States |
| STAT Research, Inc. /ID# 213933 | Vandalia | Ohio | 45377-9464 | United States |
| West Tennessee Research Inst /ID# 208838 | Jackson | Tennessee | 38305 | United States |
| PCCR Solution /ID# 215457 | Colleyville | Texas | 76034 | United States |
| Trinity Universal Research Association /ID# 209167 | Plano | Texas | 75024-5283 | United States |
| Charite Research Organisation GmbH /ID# 210216 | Berlin | 10117 | Germany |
| CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055 | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159 | Balatonfüred | Veszprém megye | 8230 | Hungary |
| Budai Irgalmasrendi Korhaz /ID# 208877 | Budapest | 1023 | Hungary |
| Debreceni Egyetem Klinikai Kozpont /ID# 210164 | Debrecen | 4032 | Hungary |
| Rambam Health Care Campus /ID# 212747 | Haifa | 3109601 | Israel |
| Sheba Medical Center /ID# 211339 | Ramat Gan | 5239424 | Israel |
| Academisch Medical center Amsterdam /ID# 209303 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| SANUS Szpital Specjalistyczny /ID# 209022 | Stalowa Wola | 37-450 | Poland |
| Reumatika - Centrum Reumatologii NZOZ /ID# 209220 | Warsaw | 02-691 | Poland |
| GCM Medical Group, PSC /ID# 208154 | San Juan | 00909 | Puerto Rico |
| Mindful Medical Research /ID# 208403 | San Juan | 00918-3756 | Puerto Rico |
Participants were administered 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2: Weeks 12 to Week 24 |
|
|
The Full Analysis Set (FAS) includes all randomized participants who received at least 1 dose of the study drugs.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22. |
| BG001 | ABBV-3373 Followed by Placebo | Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Duration of RA Symptoms | Mean | Standard Deviation | years |
| |||||||||||||||
| Duration of RA Diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Baseline Use of Systemic Glucocorticoids | Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/day prednisone equivalent) for treatment of rheumatoid arthritis at Baseline). | Count of Participants | Participants |
| |||||||||||||||
| Prior Exposure to Non-anti-TNF or Targeted Synthetic DMARDs | Randomization was stratified by prior exposure to non-anti-TNF biologics or targeted synthetic DMARDs (< 3 months and terminated not due to lack of efficacy or intolerance). | Count of Participants | Participants |
| |||||||||||||||
| Disease Activity Score 28 C-reactive protein (DAS28[CRP]) | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP) (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. | Mean | Standard Deviation | units on a scale |
|
| 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 | Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. | Participants in the full analysis set with non-missing Baseline and at least one post-baseline value are included in the analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI) | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) | The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR]) | The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity. | Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity. | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline and Week 12 |
|
From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: ABBV-3373 | Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks. | 0 | 31 | 4 | 31 | 4 | 31 |
| EG001 | Period 1: Adalimumab | Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks. | 0 | 17 | 0 | 17 | 12 | 17 |
| EG002 | Period 2: ABBV-3773 / Placebo | Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24. | 0 | 30 | 0 | 30 | 7 | 30 |
| EG003 | Period 2: Adalimumab / Adalimumab | Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24. | 0 | 16 | 2 | 16 | 12 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANAPHYLACTIC SHOCK | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BREAST ABSCESS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PERIORBITAL SWELLING | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MOUTH SWELLING | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INFUSION SITE BRUISING | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INJECTION SITE PRURITUS | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TYPE I HYPERSENSITIVITY | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| MYCOPLASMA TEST POSITIVE | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BRONCHIAL HYPERREACTIVITY | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2020 | Jun 29, 2021 | SAP_001.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000726498 | ABBV-3373 |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 40 to 65 years |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Other |
|
| No |
|
| No |
|
| Superiority |
| The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab > 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29. | Historical data borrowing | Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean < 0 given the observed data was calculated. | 0.899 | Posterior probability | Superiority |
| The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data. | Mixed Effect Model Repeated Measurement | Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate. | 0.683 | LS Mean Difference | -0.15 | Standard Error of the Mean | 0.353 | 2-Sided | 90 | -0.74 | 0.45 | Treatment difference = ABBV-3373 - Adalimumab | Superiority |
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