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| ID | Type | Description | Link |
|---|---|---|---|
| H9B-JE-BCDL | Other Identifier | Eli Lilly and Company |
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The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30mg/120 mg LY2127399 | Experimental | Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study. |
|
| 120 mg LY2127399 | Experimental | Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 | Drug | Administered subcutaneously every 4 weeks for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module. | Baseline up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody | Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement. | Baseline and Weeks 12, 24, 36, 52, and 72 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST ) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 460-0001 |
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Participants who completed NCT01253226 [Study H9B-JE-BCDK (BCDK)] were enrolled into open-label study NCT01253291 [H9B-JE-BCDL (BCDL]).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/LY2127399 120 mg Q4W | Participants who previously received placebo in Study BCDK were assigned to receive 120 milligrams (mg) of LY2127399 administered subcutaneously (SC) once every 4 weeks (Q4W) for 48 weeks. |
| FG001 | LY2127399 30 mg Q4W/120 mg Q4W | Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| FG002 | LY2127399 60 mg Q4W/120 mg Q4W | Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| FG003 | LY2127399 120 mg Q4W/120 mg Q4W | Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| FG004 | LY2127399 120 mg Q2W/120 mg Q4W | Participants who previously received 120 mg of LY2127399 every 2 weeks (Q2W) in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/LY2127399 120 mg Q4W | Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| BG001 | LY2127399 30 mg Q4W/120 mg Q4W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module. | All enrolled participants who received at least 1 dose of study drug during BCDL. | Posted | Count of Participants | Participants | No | Baseline up to 72 weeks |
|
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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 | Placebo/LY2127399 120 mg Q4W | Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C575974 | tabalumab |
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| Percent Change From Baseline in Rheumatoid Factor (RF) |
RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms. |
| Baseline and Weeks 12, 24, 36, 52, and 72 |
| Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA] | IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |
| Percent Change From Baseline in CD20+ B-cell Count | CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |
| Percent Change From Baseline in Peripheral B-cell Subsets | Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |
| Percent Change From Baseline in C-Reactive Protein (CRP) | CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |
| Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 2892511 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukui | 910-0067 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gunma | 370-0053 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 673-1462 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ibaraki | 311-3516 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 252-0392 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miyagi | 982-0032 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 152-8902 | Japan |
| Adverse Event |
|
| Lack of Efficacy |
|
| Physician Decision |
|
Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
| BG002 | LY2127399 60 mg Q4W/120 mg Q4W | Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| BG003 | LY2127399 120 mg Q4W/120 mg Q4W | Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| BG004 | LY2127399 120 mg Q2W/120 mg Q4W | Participants who previously received 120 mg of LY2127399 Q2W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| OG002 | LY2127399 60 mg Q4W/120 mg Q4W | Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| OG003 | LY2127399 120 mg Q4W/120 mg Q4W | Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
| OG004 | LY2127399 120 mg Q2W/120 mg Q4W | Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. |
|
|
| Secondary | Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody | Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement. | All enrolled participants with an anti-CCP antibody assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of Anti-CCP | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in Rheumatoid Factor (RF) | RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms. | All enrolled participants who had 1 or more RF assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of RF | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA] | IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms. | All enrolled participants with IgG, IgM or IgA assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of Ig | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in CD20+ B-cell Count | CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms. | All enrolled participants with CD20+ B-Cell assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of cells | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in Peripheral B-cell Subsets | Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms. | All enrolled participants with Mature Naive B-Cells and Switched Memory B-Cells assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of Cells | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in C-Reactive Protein (CRP) | CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms. | All enrolled participants with a CRP assessment at 1 or more of the specified timepoints. | Posted | Mean | Standard Deviation | Percent Change of CRP | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| Secondary | Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms. | All enrolled participants with an ESR assessment at 1 or more of the specific timepoints. | Posted | Mean | Standard Deviation | Percent Change of ESR | Baseline and Weeks 12, 24, 36, 52, and 72 |
|
|
|
| 1 |
| 6 |
| 5 |
| 6 |
| EG001 | LY2127399 30 mg Q4W/120 mg Q4W | Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. | 0 | 6 | 4 | 6 |
| EG002 | LY2127399 60 mg Q4W/120 mg Q4W | Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. | 0 | 4 | 4 | 4 |
| EG003 | LY2127399 120 mg Q4W/120 mg Q4W | Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. | 0 | 5 | 3 | 5 |
| EG004 | LY2127399 120 mg Q2W/120 mg Q4W | Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. | 0 | 5 | 4 | 5 |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Anti-CCP Week 36 |
|
|
| Anti-CCP Week 52 |
|
|
| Anti-CCP Week 72 |
|
|
|
| RF Week 36 |
|
|
| RF Week 52 |
|
|
| RF Week 72 |
|
|
|
| IgG Week 36 |
|
|
| IgG Week 52 |
|
|
| IgG Week 72 |
|
|
| IgM Week 12 |
|
|
| IgM Week 24 |
|
|
| IgM Week 36 |
|
|
| IgM Week 52 |
|
|
| IgM Week 72 |
|
|
| IgA Week 12 |
|
|
| IgA Week 24 |
|
|
| IgA Week 36 |
|
|
| IgA Week 52 |
|
|
| IgA Week 72 |
|
|
|
| CD20+ B Week 36 |
|
|
| CD20+ B Week 52 |
|
|
| CD20+ B Week 72 |
|
|
|
| Mature Naive B-Cell Week 36 |
|
|
| Mature Naive B-Cell Week 52 |
|
|
| Mature Naive B-Cell Week 72 |
|
|
| Switched Memory B-Cell Week 12 |
|
|
| Switched Memory B-Cell Week 24 |
|
|
| Switched Memory B-Cell Week 36 |
|
|
| Switched Memory B-Cell Week 52 |
|
|
| Switched Memory B-Cell Week 72 |
|
|
|
| CRP Week 36 |
|
|
| CRP Week 52 |
|
|
| CRP Week 72 |
|
|
|
| ESR Week 36 |
|
|
| ESR Week 52 |
|
|
| ESR Week 72 |
|
|