Rheumatoid ArthritisPhase 1NCT01253291

A Study of Japanese Rheumatoid Arthritis Participants

A Phase 1 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 9 sites in Japan.

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

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Read more about this study

Who is it for?: Ages 20 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?: No, everyone receives an active treatment
How many people: 26 participants
Where: 9 sitesJapan
Study dates: May 2010to Mar 2014
Phase: Phase 1
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 20 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 pregnant, breastfeeding or be at risk to become pregnant during study participation
Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)]

Who cannot join

Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Japan9 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.
Aichi, 460-0001
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, 2892511
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukui, 910-0067
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gunma, 370-0053
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyōgo, 673-1462
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ibaraki, 311-3516
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, 252-0392
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miyagi, 982-0032
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, 152-8902

Other trials in Japan

About this study

Official title: An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

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

What participants receive

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

LY2127399Drug
Also called tabalumab
Administered subcutaneously every 4 weeks for 48 weeks

Study groups in NCT01253291
Study group	Role	What they receive
30mg/120 mg LY2127399	Experimental	Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study. Receives: Drug: LY2127399
120 mg LY2127399	Experimental	Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed. Receives: Drug: LY2127399

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
Measured: Baseline up to 72 weeks

Secondary outcomes (7)

Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Rheumatoid Factor (RF)
RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Peripheral B-cell Subsets
Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.
Measured: Baseline and Weeks 12, 24, 36, 52, and 72

Timeline

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

May 2010Mar 2014

First posted3 Dec 2010 (estimated)
Study startMay 2010
Primary completionSep 2013
Study completionMar 2014

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.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253291
Sponsor's protocol ID: 13417
Other IDs: H9B-JE-BCDL
Status last verified: Oct 2018
First submitted: 1 Dec 2010
Last updated: 1 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. 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 Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
ClinicalTrials.gov ID: NCT01253291
Acronym / sponsor ID: 13417
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Sep 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 1 Mar 2019

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
30mg/120 mg LY2127399	Experimental	Drug: LY2127399Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.
120 mg LY2127399	Experimental	Drug: LY2127399Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.

Who may qualify

Ages: 20 to 75 years
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
Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)]

Key exclusion criteria (2 listed)

Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

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
LY2127399Also: tabalumabAdministered subcutaneously every 4 weeks for 48 weeks	Drug	120 mg LY2127399, 30mg/120 mg LY2127399

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 72 weeks
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.

7 secondary outcomes

Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Rheumatoid Factor (RF)
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in CD20+ B-cell Count
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Peripheral B-cell Subsets
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in C-Reactive Protein (CRP)
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Weeks 12, 24, 36, 52, and 72

Results and safety

Results posted to the registry on 1 Mar 2019, 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/LY2127399 120 mg Q4W	6	2
LY2127399 30 mg Q4W/120 mg Q4W	6	4
LY2127399 60 mg Q4W/120 mg Q4W	4	4
LY2127399 120 mg Q4W/120 mg Q4W	5	5
LY2127399 120 mg Q2W/120 mg Q4W	5	3

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to 72 weeks. Count of participants. Unit: Participants

Measure	Placebo/LY2127399 120 mg Q4W n = 6	LY2127399 30 mg Q4W/120 mg Q4W n = 6	LY2127399 60 mg Q4W/120 mg Q4W n = 4	LY2127399 120 mg Q4W/120 mg Q4W n = 5	LY2127399 120 mg Q2W/120 mg Q4W n = 5
SAEs	0	0	0	0	0
Treatment Emergent Other Non-Serious AEs	5	4	4	3	4

Population analysed: All enrolled participants who received at least 1 dose of study drug during BCDL.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/LY2127399 120 mg Q4W	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
LY2127399 30 mg Q4W/120 mg Q4W	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
LY2127399 60 mg Q4W/120 mg Q4W	0 of 4 (0%)	4 of 4 (100%)	Not reported
LY2127399 120 mg Q4W/120 mg Q4W	0 of 5 (0%)	3 of 5 (60%)	Not reported
LY2127399 120 mg Q2W/120 mg Q4W	0 of 5 (0%)	4 of 5 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 9 sites in Japan.

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 2 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 1 Mar 2019). 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 With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 72 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 NCT01253291.

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 1 Mar 2019.