An Open Label Extension Study in Participants With Rheumatoid Arthritis
24 marzo 2018 aggiornato da: Eli Lilly and Company
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
182
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- 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.
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Vienna, Austria, 1100
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Liege, Belgio, 4000
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Campinas, Brasile, 13015-011
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Curitiba, Brasile, 80060-240
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Goiania, Brasile, 74605-050
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Porto Alegre, Brasile, 90610-970
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Setor Oeste/Goiania, Brasile, 74100-125
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M4
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Ontario
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Hamilton, Ontario, Canada, N2M 5N6
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Kitchener, Ontario, Canada, N2M 5N6
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Santiago, Chile
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Valdivia, Chile
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Vina Del Mar, Chile
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Hildesheim, Germania, 31134
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Leipzig, Germania, 04103
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Lucknow, India, 226018
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Pune, India, 411001
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Secunderabad, India, 500003
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Chihuahua, Messico, 31000
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Cuernavaca, Messico, 62270
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Guadalajara, Messico, 44100
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Mexico City, Messico, 06700
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Monterrey, Messico, 64000
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San Luis Potosi, Messico, 78210
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Tampico, Messico, 89000
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Bialystok, Polonia, 15-337
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Chelm Slaski, Polonia, 41-403
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Elblag, Polonia, 82-300
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Krakow, Polonia, 30-510
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Lubin, Polonia, 20-022
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Lublin, Polonia, 20-954
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Poznan, Polonia, 60-356
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Torun, Polonia, 87-100
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Warsaw, Polonia, 00-235
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Wroclaw, Polonia, 50-088
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San Juan, Porto Rico, 00918
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Brasov, Romania, 500365
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Targu-Mures, Romania, 540136
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
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Huntsville, Alabama, Stati Uniti, 35801
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Arizona
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Mesa, Arizona, Stati Uniti, 85208
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California
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Palm Desert, California, Stati Uniti, 92260
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Riverside, California, Stati Uniti, 92501
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Santa Maria, California, Stati Uniti, 93454
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Upland, California, Stati Uniti, 91786
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Florida
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Jupiter, Florida, Stati Uniti, 33458
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Vero Beach, Florida, Stati Uniti, 32960
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Zephyrhills, Florida, Stati Uniti, 33542
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Maryland
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Baltimore, Maryland, Stati Uniti, 21239
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63141
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North Carolina
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Hickory, North Carolina, Stati Uniti, 28601
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Ohio
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Middleburg Heights, Ohio, Stati Uniti, 44130
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19152
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South Carolina
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Orangeburg, South Carolina, Stati Uniti, 29118
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38119
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Texas
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Dallas, Texas, Stati Uniti, 75231
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Mesquite, Texas, Stati Uniti, 75150
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Budapest, Ungheria, 1023
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Esztergom, Ungheria, 2500
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Kistarcsa, Ungheria, 2143
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Szolnok, Ungheria, 5000
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Have given written informed consent
- Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
- Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Exclusion Criteria:
- Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
- Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
- Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: LY2127399
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60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
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A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started.
Clinically significant events were defined as SAEs and other non-serious adverse events (AEs).
A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Participants were on treatment up to 48 weeks.
If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52).
If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
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Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
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Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Lasso di tempo: Baseline through Week 112
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For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified.
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
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Baseline through Week 112
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
Lasso di tempo: Baseline, up to and through Week 52
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The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
Joints were assessed by pressure and joint manipulation on physical examination.
The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions.
Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in tender joint count indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
Lasso di tempo: Baseline, up to and through Week 52
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The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
Joints were classified as either swollen or not swollen.
Swelling was defined as palpable fluctuating synovitis of the joint.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in swollen joint count indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Lasso di tempo: Baseline, up to and through Week 52
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Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in disease activity score indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Lasso di tempo: Baseline, up to and through Week 52
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Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in disease activity score indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
Lasso di tempo: Baseline, up to and through Week 52
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The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
Lasso di tempo: Baseline, up to and through Week 52
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Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in joint pain indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
Lasso di tempo: Baseline, up to and through Week 52
|
CRP is an indicator of inflammation.
The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A negative change indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants Achieving ACR20 Response
Lasso di tempo: Baseline, up to and through Week 52
|
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as non-responder imputation (NRI)/LOCF.
Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants ACR50 Response
Lasso di tempo: Baseline, up to and through Week 52
|
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as NRI/LOCF.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants Achieving ACR70 Response
Lasso di tempo: Baseline, up to and through Week 52
|
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as NRI/LOCF.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
ACR-N Response
Lasso di tempo: Baseline, up to and through Week 52
|
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned.
Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
Lasso di tempo: Baseline, up to and through Week 52
|
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items.
Scores ranged from 0 to 52, where higher scores indicated less fatigue.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
An increase in FACIT fatigue score indicated an improvement of the participant's condition.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
Lasso di tempo: Baseline, up to and through Week 52
|
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS).
The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square
root(TJC28)+0.28*square
root(SJC28)+0.36*natural
log(CRP+1)+0.014*participant
global VAS+0.96.
Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in DAS28 indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
Lasso di tempo: Baseline, up to and through Week 52
|
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved.
DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS).
EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u).
Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Percentage of participants=(number of participants with specific response/participants assessed)*100.
Displayed percentages may not add up to 100% because of rounding.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Lasso di tempo: Baseline, up to and through Week 52
|
SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health).
Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status.
The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100).
The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Lasso di tempo: Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in cell count.
|
Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Lasso di tempo: Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets.
Cell surface markers were defined as being either present (+) or absent (-).
Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+).
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in cell count.
|
Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
|
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
Lasso di tempo: Baseline, up to Week 52
|
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses.
Their normal blood levels indicate proper immune status.
Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in immunoglobulin levels.
|
Baseline, up to Week 52
|
|
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
Lasso di tempo: Baseline, Week 52
|
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis.
Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
A decrease in RF levels indicated an improvement in the participant's condition.
Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
|
Baseline, Week 52
|
|
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
Lasso di tempo: Baseline, up to Week 52
|
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method.
In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
|
Baseline, up to Week 52
|
|
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Lasso di tempo: Baseline, up to Week 52
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assessed the rate at which red blood cells fell in a test tube.
Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory.
Higher scores indicated greater inflammation.
Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
A decrease in ESR indicated an improvement in the participant's condition.
|
Baseline, up to Week 52
|
|
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Lasso di tempo: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)
|
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported.
Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.
The number of participants with baseline positive ADA data is also reported.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
|
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Who Died, Any Cause
Lasso di tempo: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)
|
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Participants were on treatment up to 48 weeks.
If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52).
If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards.
After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
|
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST), Eli Lilly and Company
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2009
Completamento primario (Effettivo)
1 gennaio 2011
Completamento dello studio (Effettivo)
1 gennaio 2012
Date di iscrizione allo studio
Primo inviato
3 febbraio 2009
Primo inviato che soddisfa i criteri di controllo qualità
3 febbraio 2009
Primo Inserito (Stima)
5 febbraio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 aprile 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 marzo 2018
Ultimo verificato
1 marzo 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11768
- H9B-MC-BCDI (Altro identificatore: Eli Lilly and Company)
- CTRI/2009/091/000765 (Identificatore di registro: India)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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