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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003881-42 | EudraCT Number |
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A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.
All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New formulation of adalimumab 40 mg every other week | Experimental | New formulation adalimumab 40 mg every other week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New formulation adalimumab | Biological | New formulation adalimumab 40 mg every other week |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 | The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 | American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
| Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 | American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
| Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Positive for Anti-adalimumab Antibody | Percentage of participants with anti-adalimumab antibody | Week 24 through Week 48 |
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Inclusion Criteria:
Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andy Payne, PhD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 92113 | Mesa | Arizona | 85202 | United States | ||
| Site Reference ID/Investigator# 92118 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Formulation for 48 Weeks | New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week |
| FG001 | Current Formulation for 24 Weeks, New Formulation for 24 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. |
| Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| Hemet |
| California |
| 92543 |
| United States |
| Site Reference ID/Investigator# 92117 | Wichita | Kansas | 67203 | United States |
| Site Reference ID/Investigator# 92115 | Clifton | New Jersey | 07012 | United States |
| Site Reference ID/Investigator# 92116 | Philadelphia | Pennsylvania | 19152 | United States |
| Site Reference ID/Investigator# 92114 | Charleston | South Carolina | 29406 | United States |
| Site Reference ID/Investigator# 92053 | Brussels | 1200 | Belgium |
| Site Reference ID/Investigator# 92054 | Liège | 4000 | Belgium |
| Site Reference ID/Investigator# 91954 | Brno | 638 00 | Czechia |
| Site Reference ID/Investigator# 91955 | Prague | 128 50 | Czechia |
| Site Reference ID/Investigator# 91953 | Uherské Hradiště | 686 01 | Czechia |
| Site Reference ID/Investigator# 91956 | Zlín | 760 01 | Czechia |
| Site Reference ID/Investigator# 92073 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 92074 | Vega Baja | 00693 | Puerto Rico |
| Site Reference ID/Investigator# 92093 | Bucharest | 020475 | Romania |
| Site Reference ID/Investigator# 92095 | Cluj-Napoca | 400006 | Romania |
| Site Reference ID/Investigator# 92094 | Ploieşti | 100337 | Romania |
| Site Reference ID/Investigator# 92096 | Banská Bystrica | 97405 | Slovakia |
| Site Reference ID/Investigator# 92097 | Senica | 905 01 | Slovakia |
| Site Reference ID/Investigator# 92098 | Žilina | 010 01 | Slovakia |
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week |
| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | New Formulation for 48 Weeks | New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week |
| BG001 | Current Formulation for 24 Weeks, New Formulation for 24 Weeks | Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 | The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
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| Primary | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 | American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
| All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 | American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
| All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. | Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 |
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| Secondary | Percentage of Participants Positive for Anti-adalimumab Antibody | Percentage of participants with anti-adalimumab antibody | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Week 24 through Week 48 |
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Adverse events were collected from the time of study drug administration until 70 days following the last dose, approximately 58 weeks. Serious adverse events were collected from the time the participant signed the informed consent.
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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 | New Formulation for 48 Weeks | New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week. | 2 | 44 | 18 | 44 | ||
| EG001 | Current Formulation for 24 Weeks, New Formulation for 24 Weeks | Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week | 1 | 44 | 19 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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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 (prior sponsor, Abbott) | 800-633-9110 |
| 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 |
|---|---|
| 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 |
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| Units | Counts |
|---|---|
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| Participants |
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| Current Formulation for 24 Weeks, New Formulation for 24 Weeks |
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week |
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