Rheumatoid ArthritisPhase 2NCT00785928

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

A Phase 2 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 48 sites in 12 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

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
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: 158 participants
Where: 48 sitesin 12 countries
Study dates: Oct 2008to Dec 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
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis (RA)
Current, regular use of Methotrexate, at a stable dose
Other criteria to be reviewed by study doctor

Who cannot join

Use of excluded medications(reviewed by study doctor)
Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Evidence of tuberculosis
Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
Other criteria to be reviewed by study doctor

Trial locations and contacts

48 sites in 12 countries.

Country

City, postcode or hospital

48 sites in 12 countries

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, 02-777
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Wroclaw, 50-088

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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, 64020
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San Luis Potosí City, 78210
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Tampico, 89000

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United States6 sites

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Calabasas, California, 91302
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Dallas, Texas, 75235
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Huntsville, Alabama, 35801
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Philadelphia, Pennsylvania, 19152
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Upland, California, 91786
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Vero Beach, Florida, 32960

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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

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India4 sites

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Hyderabaad, 400082
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Lucknow, 226018
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Pune, 411001
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Secunderabad, 800003

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Ukraine4 sites

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Ivano-Frankivsk, 76018
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Kiev, 1601
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Odesa, 65027
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Simferopol, 95017

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Australia3 sites

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Brisbane, Queensland, 4066
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Elizabeth Vale, South Australia, 5112
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Maroochydore, Queensland, 4558

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Chile3 sites

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Santiago
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Valdivia
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Viña del Mar

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Argentina2 sites

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Buenos Aires, C1417EYG
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Quilmes, 1878

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Romania2 sites

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Brasov, 500365
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Târgu Mureş, 540136

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Slovakia2 sites

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Bratislava, 83103
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Rimavska, 97101

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Germany1 site

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Leipzig, 04103

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About this study

Official title: Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Conditions: Rheumatoid Arthritis
Being tested: LY2127399, Placebo
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
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
PlaceboDrug
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

Study groups in NCT00785928
Study group	Role	What they receive
Placebo	Experimental	Not described Receives: Drug: Placebo
1 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399
3 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399
10 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399
30 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399
60 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399
120 mg LY2127399	Experimental	Not described Receives: Biological: LY2127399

What is being measured

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

Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant 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: Up to week 24

Secondary outcomes (17)

Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks
ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as 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, participant 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: Up to 24 weeks
Change From Baseline in the Tender Joint Count up to 24 Weeks
Number of tender and painful joints was 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. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.
Measured: Baseline, up to 24 weeks
Change From Baseline in Swollen Joint Count up to 24 Weeks
The number of swollen joints was determined by examination of 28 joints 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. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks
DAS (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 his or her disease activity (participant global visual analog scale [pt global VAS]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Measured: Baseline, up to 24 weeks
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. 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 (participant global visual analog scale [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: Up to 24 weeks
Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks
Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks
Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks
Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks
Participant's assessment of physical function. Disability section of questionnaire scores participant's self-perception on 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, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).
Measured: Baseline, up to 24 weeks
Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks
Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks
The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.
Measured: Baseline, up to 24 weeks
Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks
A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).
Measured: Baseline, up to 24 weeks
Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks
C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.
Measured: 24 weeks
Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks
T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.
Measured: 24 weeks
Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks
B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 - 602 cells/µL.
Measured: Baseline, up to 24 weeks
Change From Baseline in Serum Immunoglobulin up to 24 Weeks
Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.
Measured: Baseline, up to 24 weeks
Number of Participants Experiencing An Adverse Event
Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Measured: Baseline up to 24 weeks

Timeline

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

Oct 2008Dec 2010

First posted5 Nov 2008 (estimated)
Study startOct 2008
Primary completionJan 2010
Study completionDec 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 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00785928
Sponsor's protocol ID: 12409
Other IDs: H9B-MC-BCDH
Status last verified: Jun 2018
First submitted: 3 Nov 2008
Last updated: 10 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Genovese MC, Lee E, Satterwhite J, Veenhuizen M, Disch D, Berclaz PY, Myers S, Sides G, Benichou O. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2013 Sep 1;72(9):1453-60. doi: 10.1136/annrheumdis-2012-202864. Epub 2013 Apr 18.
PubMed 23599435

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
ClinicalTrials.gov ID: NCT00785928
Acronym / sponsor ID: 12409
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jan 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 5 Nov 2008 (estimated)
Results: Posted 10 Jul 2018

Clinical summary

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

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Placebo	Experimental	Drug: Placebo
1 mg LY2127399	Experimental	Biological: LY2127399
3 mg LY2127399	Experimental	Biological: LY2127399
10 mg LY2127399	Experimental	Biological: LY2127399
30 mg LY2127399	Experimental	Biological: LY2127399
60 mg LY2127399	Experimental	Biological: LY2127399
120 mg LY2127399	Experimental	Biological: LY2127399

Who may qualify

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

Key inclusion criteria (5 listed)

Have given written informed consent
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis (RA)
Current, regular use of Methotrexate, at a stable dose
Other criteria to be reviewed by study doctor

Key exclusion criteria (6 listed)

Use of excluded medications(reviewed by study doctor)
Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Evidence of tuberculosis
Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy

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
LY2127399Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).	Biological	1 mg LY2127399, 10 mg LY2127399, 120 mg LY2127399, 3 mg LY2127399, 30 mg LY2127399, 60 mg LY2127399
PlaceboAdministered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).	Drug	Placebo

Primary outcome

Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
Time frame: Up to week 24
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant 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.

17 secondary outcomes

Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks
Time frame: Up to 24 weeks
Change From Baseline in the Tender Joint Count up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in Swollen Joint Count up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
Time frame: Up to 24 weeks
Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks
Time frame: 24 weeks
Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks
Time frame: 24 weeks
Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Change From Baseline in Serum Immunoglobulin up to 24 Weeks
Time frame: Baseline, up to 24 weeks
Number of Participants Experiencing An Adverse Event
Time frame: Baseline up to 24 weeks

Results and safety

Results posted to the registry on 10 Jul 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
Placebo	36	33
1 mg LY2127399	30	25
3 mg LY2127399	20	17
10 mg LY2127399	15	15
30 mg LY2127399	18	16
60 mg LY2127399	13	13
120 mg LY2127399	26	23

Primary outcome: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks

Time frame: Up to week 24. Number. Unit: percentage of participants

Measure	Placebo n = 36	1 mg LY2127399 n = 30	3 mg LY2127399 n = 20	10 mg LY2127399 n = 15	30 mg LY2127399 n = 18	60 mg LY2127399 n = 13	120 mg LY2127399 n = 24
Value	18.1	17.7	17.0	15.0	11.8	11.8	37.0

Placebo vs 1 mg LY2127399 vs 3 mg LY2127399 vs 10 mg LY2127399 vs 30 mg LY2127399 vs 60 mg LY2127399 vs 120 mg LY2127399: p = 0.059, Linear-quadratic regression model
Placebo vs 1 mg LY2127399 vs 3 mg LY2127399 vs 10 mg LY2127399 vs 30 mg LY2127399 vs 60 mg LY2127399 vs 120 mg LY2127399: ED95: 119.0, p = 0.042, Linear-quadratic regression model

Population analysed: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). Two participants were excluded due to Good Clinical Practice (GCP) issues.

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 36 (13.9%)	21 of 36 (58.3%)	Not reported
1 mg LY2127399	4 of 30 (13.3%)	19 of 30 (63.3%)	Not reported
3 mg LY2127399	0 of 20 (0%)	12 of 20 (60%)	Not reported
10 mg LY2127399	0 of 15 (0%)	9 of 15 (60%)	Not reported
30 mg LY2127399	3 of 18 (16.7%)	11 of 18 (61.1%)	Not reported
60 mg LY2127399	2 of 13 (15.4%)	8 of 13 (61.5%)	Not reported
120 mg LY2127399	1 of 26 (3.8%)	13 of 26 (50%)	Not reported
Placebo - Follow-up Period	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
1 mg LY2127399 - Follow-up Period	0 of 8 (0%)	2 of 8 (25%)	Not reported
3 mg LY2127399 - Follow-up Period	1 of 6 (16.7%)	1 of 6 (16.7%)	Not reported
10 mg LY2127399 - Follow-up Period	0 of 4 (0%)	3 of 4 (75%)	Not reported
30 mg LY2127399 - Follow-up Period	1 of 6 (16.7%)	3 of 6 (50%)	Not reported
60 mg LY2127399 - Follow-up Period	0 of 0	0 of 0	Not reported
120 mg LY2127399 - Follow-up Period	0 of 14 (0%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23599435Genovese MC, Lee E, Satterwhite J, Veenhuizen M, Disch D, Berclaz PY, Myers S, Sides G, Benichou O. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2013 Sep 1;72(9):1453-60. doi: 10.1136/annrheumdis-2012-202864. Epub 2013 Apr 18.

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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 - 5PM Eastern Time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

48 sites in 12 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 48 sites in 12 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 5 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Poland, Mexico, United States, Hungary, India and 7 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 10 Jul 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 Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks (time frame: Up to week 24). 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 NCT00785928, 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 10 Jul 2018.