Rheumatoid ArthritisPhase 2NCT00837811
An Open Label Extension Study in Participants With Rheumatoid Arthritis
A Phase 2 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 62 sites in 14 countries.
Trial summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY2127399
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 62 sitesin 14 countries
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
62 sites in 14 countries.
62 sites in 14 countries
United States19 sites
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Baltimore, Maryland, 21239
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Birmingham, Alabama, 35205
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Dallas, Texas, 75231
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Hickory, North Carolina, 28601
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Huntsville, Alabama, 35801
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Jupiter, Florida, 33458
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Memphis, Tennessee, 38119
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Mesa, Arizona, 85208
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Mesquite, Texas, 75150
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Middleburg Heights, Ohio, 44130
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Orangeburg, South Carolina, 29118
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Palm Desert, California, 92260
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Philadelphia, Pennsylvania, 19152
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Riverside, California, 92501
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Santa Maria, California, 93454
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St Louis, Missouri, 63141
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Upland, California, 91786
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Vero Beach, Florida, 32960
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Zephyrhills, Florida, 33542
Poland10 sites
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Bialystok, 15-337
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Chełm Śląski, 41-403
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Elblag, 82-300
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Krakow, 30-510
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Lubin, 20-022
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Lublin, 20-954
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Poznan, 60-356
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Torun, 87-100
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Warsaw, 00-235
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Wroclaw, 50-088
Mexico7 sites
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Chihuahua City, 31000
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Cuernavaca, 62270
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Guadalajara, 44100
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Mexico City, 06700
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Monterrey, 64000
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San Luis Potosí City, 78210
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Tampico, 89000
Brazil5 sites
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Campinas, 13015-011
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Curitiba, 80060-240
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Goiânia, 74605-050
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Porto Alegre, 90610-970
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Setor Oeste/Goiania, 74100-125
Hungary4 sites
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Budapest, 1023
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Esztergom, 2500
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Kistarcsa, 2143
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Szolnok, 5000
Canada3 sites
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Hamilton, Ontario, N2M 5N6
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Kitchener, Ontario, N2M 5N6
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Winnipeg, Manitoba, R3A 1M4
Chile3 sites
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Santiago
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Valdivia
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Viña del Mar
India3 sites
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Lucknow, 226018
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Pune, 411001
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Secunderabad, 500003
Germany2 sites
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Hildesheim, 31134
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Leipzig, 04103
Romania2 sites
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Brasov, 500365
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Târgu Mureş, 540136
Australia1 site
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Elizabeth Vale, South Australia, 5112
Austria1 site
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Vienna, 1100
Belgium1 site
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Liège, 4000
Puerto Rico1 site
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San Juan, 00918
About this study
Official title: 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- LY2127399
- Keywords
- Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2127399Biological
60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| LY2127399 | Experimental | Not described Receives: Biological: LY2127399 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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)].
Measured: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
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)].
Measured: Baseline through Week 112
Secondary outcomes (22)
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
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.
Measured: Baseline, up to and through Week 52
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
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.
Measured: Baseline, up to and through Week 52
Percentage of Participants Achieving ACR20 Response
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.
Measured: Baseline, up to and through Week 52
Percentage of Participants ACR50 Response
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.
Measured: Baseline, up to and through Week 52
Percentage of Participants Achieving ACR70 Response
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.
Measured: Baseline, up to and through Week 52
ACR-N Response
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
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.
Measured: Baseline, up to and through Week 52
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
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.
Measured: Baseline, up to and through Week 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
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.
Measured: Baseline, up to and through Week 52
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
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.
Measured: Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
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.
Measured: Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
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.
Measured: Baseline, up to Week 52
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at 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.
Measured: Baseline, Week 52
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
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.
Measured: Baseline, up to Week 52
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
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.
Measured: Baseline, up to Week 52
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837811
- Sponsor's protocol ID
- 11768
- Other IDs
- H9B-MC-BCDI, CTRI/2009/091/000765
- Status last verified
- Mar 2018
- First submitted
- 3 Feb 2009
- Last updated
- 25 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
PubMed 25168268
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00837811
- Acronym / sponsor ID
- 11768
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 25 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2127399 | Experimental | Biological: LY2127399 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY212739960 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks | Biological | LY2127399 |
Primary outcome
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
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)].
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Time frame: Baseline through Week 112
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)].
22 secondary outcomes
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
Time frame: Baseline, up to and through Week 52
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
Time frame: Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Time frame: Baseline, up to and through Week 52
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Time frame: Baseline, up to and through Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
Time frame: Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
Time frame: Baseline, up to and through Week 52
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
Time frame: Baseline, up to and through Week 52
Percentage of Participants Achieving ACR20 Response
Time frame: Baseline, up to and through Week 52
Percentage of Participants ACR50 Response
Time frame: Baseline, up to and through Week 52
Percentage of Participants Achieving ACR70 Response
Time frame: Baseline, up to and through Week 52
ACR-N Response
Time frame: Baseline, up to and through Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
Time frame: Baseline, up to and through Week 52
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
Time frame: Baseline, up to and through Week 52
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
Time frame: Baseline, up to and through Week 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Time frame: Baseline, up to and through Week 52
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Time frame: Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Time frame: Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
Time frame: Baseline, up to Week 52
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
Time frame: Baseline, Week 52
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
Time frame: Baseline, up to Week 52
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, up to Week 52
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25168268Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST) study director
Eli Lilly and Company
62 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 62 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Poland, Mexico, Brazil, Hungary and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.