Arthritis, RheumatoidPhase 2NCT00689728

A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

A Phase 2 study testing LY2127399 in people with Arthritis, Rheumatoid, run by Eli Lilly and Company at 45 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: LY2127399
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 45 sitesin 10 countries
Study dates: Jun 2008to May 2010
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis
Active Rheumatoid Arthritis
Current, regular use of Methotrexate, at a stable dose
Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
Other criteria to be reviewed by study doctor

Who cannot join

Use of excluded medications (reviewed by study doctor)
Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
Evidence of tuberculosis
Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
Other criteria to be reviewed by study doctor

Trial locations and contacts

45 sites in 10 countries.

Country

City, postcode or hospital

45 sites in 10 countries

United States19 sites

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.
Austin, Texas, 78705
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Baltimore, Maryland, 21239
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Birmingham, Alabama, 35205
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Dallas, Texas, 75235
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Hickory, North Carolina, 28601
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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

Other trials in United States

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, 74110-010

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Mexico5 sites

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Chihuahua City, 31000
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Cuernavaca, 62270
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Guadalajara, 44100
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Monterrey, 64020
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Morelia, 58240

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Argentina4 sites

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Buenos Aires, C1055AAF
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Caba, C1180AAX
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San Juan, 5400
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San Miguel de Tucumán, 4000

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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

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Germany3 sites

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Göttingen, 37075
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Hildesheim, 31134
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Vogelsang, 39245

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Poland3 sites

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Lublin, 20-954
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Torun, 87-100
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Warsaw, 00-235

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Austria1 site

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Vienna, 1100

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Belgium1 site

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Liège, 4000

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Puerto Rico1 site

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San Juan, 00918

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About this study

Official title: A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy

The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

Conditions: Arthritis, Rheumatoid
Being tested: LY2127399, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2127399Biological
LY2127399 will be administered as a single IV infusion over 30 minutes.
PlaceboDrug
Placebo will be administered as a single IV infusion over 30 minutes.

Study groups in NCT00689728
Study group	Role	What they receive
30 milligram (mg) LY2127399	Experimental	Double-blind Treatment: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery. Receives: Biological: LY2127399
80 mg LY2127399	Experimental	Double-blind Treatment: 80 mg LY2127399 administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery. Receives: Biological: LY2127399
Placebo	Placebo comparator	Double-blind Treatment: Placebo comparator administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on same initial randomized treatment up to Week 24. Follow-Up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
Measured: 16 weeks

Secondary outcomes (19)

Number of Participants Experiencing An Adverse Event
Serious adverse events and other non-serious adverse events are located in the Reported Adverse Event section.
Measured: Baseline up to 68 weeks
Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16
Self-reported questionnaire of 36 questions in 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health). Each domain is scored by summing individual items and transforming scores into a 0-100 scale (higher scores=better health status/function). The mental and physical component summaries are based on the 8 domains. Component scores are transformed scores representing a mean (50) and standard deviation (10) in the general United States (US) population. Scores > or <50 are above or below the average US population.
Measured: Baseline, 16 weeks
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as a participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
Measured: 16 weeks
Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR70 Responder is defined as a participant with at least 70% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
Measured: 16 weeks
Change From Baseline in Tender Joint Count at Week 16
The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: 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. The joints are assessed and classified as tender or not tender.
Measured: Baseline, 16 weeks
Change From Baseline in Swollen Joint Count at Week 16
The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: 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. The joints are assessed and classified as swollen or not swollen.
Measured: Baseline, 16 weeks
Change From Baseline in Participant's Assessment of Joint Pain at Week 16
Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no pain and 100 indicated worst possible pain.
Measured: Baseline, 16 weeks
Change From Baseline in Participant's Assessment of Disease Activity at Week 16
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.
Measured: Baseline, 16 weeks
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16
Physician's global assessment of arthritis disease activity using a visual analog scale (VAS) which ranged from 0 to 100 millimeters, where 0 indicates no arthritis activity and 100 indicates extremely active arthritis.
Measured: Baseline, 16 weeks
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
The HAQ-DI questionnaire scores the participant's self-perception on the degree of difficulty when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do). The scores for each of the functional areas, which have a range from 0 to 3, are averaged to calculate the functional disability index. Higher scores are associated with greater disability.
Measured: Baseline, 16 weeks
Percent Change From Baseline in C-reactive Protein (CRP) at Week 16
Measured: Baseline, 16 weeks
Change From Baseline in Disease Activity Score (DAS28) at Week 16
Disease Activity Score (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). It is calculated by using the following formula:DAS28-CRP=0.56 times the square root of(28TJC)+0.28 times the square root of(28SJC)+0.36*natural log (ln)(CRP+1)+0.014*patient global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Measured: Baseline, 16 weeks
Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16
EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28 joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).
Measured: 16 weeks
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16
The FACIT Fatigue Score is a brief patient-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.
Measured: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16
B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this endpoint, total B cell counts (CD20+CD3- cells) are represented by number of cells per microliter. The reference range for the absolute counts is 43-602 cells per microliter.
Measured: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes
B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this outcome, total B cells (CD20+CD3- cells) are expressed as the relative percent of lymphocytes. There is no reference range provided for this parameter by the performing laboratory.
Measured: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16
Serum immunoglobulin measured by Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) levels.
Measured: Baseline, 16 weeks
Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state
C-trough is defined as the concentration of LY at the end of the dosing interval at steady state. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the Ctrough values were calculated for each dose group based on simulated data.
Measured: Pre-dose, Day 1 through Week 24
Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)
T-half life (t1/2, tau) is defined as the apparent steady state elimination within the dosing interval. T-half life was obtained by conducting a simulation consisting of 1000 participants using the study drug regimens (30 and 80 mg, intravenous infusion over 30 minutes, once every 3 weeks). The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the t-half life values were calculated for each dose group based on simulated data.
Measured: Pre-dose, Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008May 2010

First posted4 Jun 2008 (estimated)
Study startJun 2008
Primary completionFeb 2010
Study completionMay 2010

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 Arthritis, RheumatoidStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689728
Sponsor's protocol ID: 11351
Other IDs: H9B-MC-BCDG
Status last verified: Nov 2018
First submitted: 2 Jun 2008
Last updated: 6 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Genovese MC, Fleischmann RM, Greenwald M, Satterwhite J, Veenhuizen M, Xie L, Berclaz PY, Myers S, Benichou O. Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors. Ann Rheum Dis. 2013 Sep 1;72(9):1461-8. doi: 10.1136/annrheumdis-2012-202775. Epub 2012 Dec 25.
PubMed 23268367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy
ClinicalTrials.gov ID: NCT00689728
Acronym / sponsor ID: 11351
Conditions: Arthritis, Rheumatoid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Feb 2010 (actual)
Study completion: May 2010 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 6 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
30 milligram (mg) LY2127399	Experimental	Biological: LY2127399Double-blind Treatment: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.
80 mg LY2127399	Experimental	Biological: LY2127399Double-blind Treatment: 80 mg LY2127399 administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.
Placebo	Placebo comparator	Drug: PlaceboDouble-blind Treatment: Placebo comparator administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on same initial randomized treatment up to Week 24. Follow-Up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis
Active Rheumatoid Arthritis
Current, regular use of Methotrexate, at a stable dose

Key exclusion criteria (6 listed)

Use of excluded medications (reviewed by study doctor)
Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
Evidence of tuberculosis
Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.

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
LY2127399LY2127399 will be administered as a single IV infusion over 30 minutes.	Biological	30 milligram (mg) LY2127399, 80 mg LY2127399
PlaceboPlacebo will be administered as a single IV infusion over 30 minutes.	Drug	Placebo

Primary outcome

Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16
Time frame: 16 weeks
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.

19 secondary outcomes

Number of Participants Experiencing An Adverse Event
Time frame: Baseline up to 68 weeks
Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16
Time frame: Baseline, 16 weeks
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
Time frame: 16 weeks
Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16
Time frame: 16 weeks
Change From Baseline in Tender Joint Count at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Swollen Joint Count at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Participant's Assessment of Joint Pain at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Participant's Assessment of Disease Activity at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Time frame: Baseline, 16 weeks
Percent Change From Baseline in C-reactive Protein (CRP) at Week 16
Time frame: Baseline, 16 weeks
Change From Baseline in Disease Activity Score (DAS28) at Week 16
Time frame: Baseline, 16 weeks
Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16
Time frame: 16 weeks
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16
Time frame: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16
Time frame: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes
Time frame: Baseline, 16 weeks
Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16
Time frame: Baseline, 16 weeks
Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state
Time frame: Pre-dose, Day 1 through Week 24
Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)
Time frame: Pre-dose, Day 1 through Week 24

Results and safety

Results posted to the registry on 6 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
30 mg LY2127399	35	31
80 mg LY2127399	30	26
Placebo	35	30

Primary outcome: Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16

Time frame: 16 weeks. Number. Unit: Percentage of Participants

Measure	30 mg LY2127399 n = 35	80 mg LY2127399 n = 28	Placebo n = 35
Value	11.4	14.3	2.9

30 mg LY2127399 vs Placebo: p = 0.178, Fisher Exact
80 mg LY2127399 vs Placebo: p = 0.116, Fisher Exact

Population analysed: Non-responder imputation/last observation carried forward (NRI/LOCF); intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR50 assessment. Two participants from sites with good clinical practice \[GCP\] violations are excluded.

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30 mg LY2127399 - Treatment	1 of 35 (2.9%)	22 of 35 (62.9%)	Not reported
80 mg LY2127399 - Treatment	2 of 30 (6.7%)	21 of 30 (70%)	Not reported
Placebo - Treatment	3 of 35 (8.6%)	22 of 35 (62.9%)	Not reported
30 mg LY2127399 - Without Rescue Treatment	0 of 19 (0%)	2 of 19 (10.5%)	Not reported
30 mg LY2127399 - With Rescue Treatment	1 of 12 (8.3%)	5 of 12 (41.7%)	Not reported
80 mg LY2127399 - Without Rescue Treatment	0 of 15 (0%)	6 of 15 (40%)	Not reported
80 mg LY2127399 - With Rescue Treatment	0 of 11 (0%)	3 of 11 (27.3%)	Not reported
Placebo - Without Rescue Treatment	0 of 10 (0%)	3 of 10 (30%)	Not reported
Placebo - With Rescue Treatment	0 of 20 (0%)	11 of 20 (55%)	Not reported
30 mg LY2127399 - Follow-up	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
80 mg LY2127399 - Follow-up	0 of 11 (0%)	4 of 11 (36.4%)	Not reported
Placebo - Follow-up	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23268367Genovese MC, Fleischmann RM, Greenwald M, Satterwhite J, Veenhuizen M, Xie L, Berclaz PY, Myers S, Benichou O. Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors. Ann Rheum Dis. 2013 Sep 1;72(9):1461-8. doi: 10.1136/annrheumdis-2012-202775. Epub 2012 Dec 25.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

45 sites in 10 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 Arthritis, Rheumatoid, run by Eli Lilly and Company at 45 sites in 10 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 7 inclusion and 6 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Brazil, Mexico, Argentina, Canada and 5 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. Some participants in this study may receive a placebo. 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 6 Dec 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?

Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16 (time frame: 16 weeks). 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 NCT00689728, 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 6 Dec 2018.