Rheumatoid ArthritisPhase 1NCT01253265
A Study in Rheumatoid Arthritis
A Phase 1 study testing LY2439821 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 8 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis. 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?
- LY2439821
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 8 sitesJapan
- Study dates
- May 2010to Dec 2011
- 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
- Ambulatory male or female patients between the ages of 20 and 75 years
- Male patients: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing. Female patients: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
- Patients who are between the body weight of 40 and 105 kilogram (kg)
- Patients who have an established diagnosis of Rheumatoid Arthritis (RA)
- Patients who have C reactive protein (CRP) measurement greater than the upper limit of normal or erythrocyte sedimentation rate of at least 28 millimeters per hour (mm/hr)
- Patients who have been treated with regular use of Methotrexate (MTX) for at least 12 weeks, and stable treatment (at least 7.5 milligrams per week (mg/week)) for at least 8 weeks
- Patients who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site
- Patients who have reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Patients who use oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent or use of variable doses of oral corticosteroids within the last 4 weeks
- Patients who have had a live vaccination within the last 12 weeks, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within the last 12 weeks
- Patients who have a diagnosis of any systemic inflammatory condition other than RA
- Patients who have evidence of active vasculitis or uveitis
- Patients who have a diagnosis of Felty's syndrome
- Patients who have had surgical treatment of a joint within the last 8 weeks, or will require it during the study
Show all 21Show fewer
- Patients who have had lymphoma, leukemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease
- Patients who have suffered a serious bacterial infection within the last 12 weeks, or a recent or ongoing infection
- Patients who have an evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test
- Patients who have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
- Patients who have an evidence of positive hepatitis B (HBV) surface antigen, positive hepatitis B surface antibody, positive hepatitis B core antibody, or hepatitis B DNA (HBV DNA); an evidence of human immunodeficiency virus (HIV), evidence of hepatitis B; or an evidence of hepatitis C
- Patients who have clinical laboratory test results at entry that are outside the normal reference range, or results with unacceptable deviations that are considered clinically significant by the investigator
- Patients who have a serum creatinine >2.0 milligrams per deciliter (mg/dL)
- Patients who have known hypogammaglobulinemia or a serum immunoglobulin (Ig) G (IgG), IgM, or IgA concentration less than the lower limit of normal
- Patients who have an abnormality in the 12 lead electrocardiogram (ECG).
- Patients who have donated of blood more than 200 mL within the past 30 days, or more than 400 milliliters (mL) within the past 90 days
- Patients who are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. For unapproved Disease-Modifying Anti-Rheumatic Drug (DMARDs), have received 30 days or 5 fold of the half life prior to inclusion whichever is longer
- Patients who previously completed or withdrawn from this study or any other study investigating LY2439821
- Patients who have been treated with any biologic DMARD currently or previously for 5 half lives
- Patients who have had serious reaction to other biologic Disease-Modifying Anti-Rheumatic Drug (DMARDs)
- Patients who have received non biologics DMARDs (other than MTX, sulfasalazine, bucillamine or hydroxychloroquine)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 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.
Fukuoka, 820-8505
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, 316-0035
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.
Nagasaki, 857-1165
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.
Niigata, 940-2085
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.
Okayama, 712-8044
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.
Shimane, 699-0293
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, 164-8541
About this study
Official title: Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment
The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LY2439821, 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.
LY2439821Drug
Administered subcutaneously
PlaceboDrug
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 30 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Receives: Drug: LY2439821 |
| 80 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Receives: Drug: LY2439821 |
| 180 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Receives: Drug: LY2439821 |
| Placebo | Placebo comparator | Placebo is administered subcutaneously in the same manner as active drug in each dose group Receives: Drug: Placebo |
| 120 mg LY2439821 | Experimental | Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week Receives: Drug: LY2439821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Effects
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Measured: Baseline up to 26 weeks
Secondary outcomes (7)
Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.
Measured: Baseline, 16 weeks
Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).
Measured: Baseline, 16 weeks
Change From Baseline to 26 Week Endpoint in Neutrophil Counts
Measured: Baseline, 26 weeks
Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
Measured: Baseline, 26 weeks
Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)
Measured: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)
Measured: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)
Measured: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253265
- Sponsor's protocol ID
- 13061
- Other IDs
- I1F-JE-RHAL
- Status last verified
- Apr 2016
- First submitted
- 1 Dec 2010
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment
- ClinicalTrials.gov ID
- NCT01253265
- Acronym / sponsor ID
- 13061
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 30 mg LY2439821 | Experimental | Drug: LY2439821Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| 80 mg LY2439821 | Experimental | Drug: LY2439821Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| 180 mg LY2439821 | Experimental | Drug: LY2439821Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered subcutaneously in the same manner as active drug in each dose group |
| 120 mg LY2439821 | Experimental | Drug: LY2439821Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ambulatory male or female patients between the ages of 20 and 75 years
- Male patients: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing. Female patients: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
- Patients who are between the body weight of 40 and 105 kilogram (kg)
- Patients who have an established diagnosis of Rheumatoid Arthritis (RA)
- Patients who have C reactive protein (CRP) measurement greater than the upper limit of normal or erythrocyte sedimentation rate of at least 28 millimeters per hour (mm/hr)
Key exclusion criteria (21 listed)
- Patients who use oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent or use of variable doses of oral corticosteroids within the last 4 weeks
- Patients who have had a live vaccination within the last 12 weeks, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within the last 12 weeks
- Patients who have a diagnosis of any systemic inflammatory condition other than RA
- Patients who have evidence of active vasculitis or uveitis
- Patients who have a diagnosis of Felty's syndrome
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 |
|---|---|---|
| LY2439821Administered subcutaneously | Drug | 120 mg LY2439821, 180 mg LY2439821, 30 mg LY2439821, 80 mg LY2439821 |
| PlaceboAdministered subcutaneously | Drug | Placebo |
Primary outcome
Number of Participants With Clinically Significant Effects
Time frame: Baseline up to 26 weeks
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
7 secondary outcomes
Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
Time frame: Baseline, 16 weeks
Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, 16 weeks
Change From Baseline to 26 Week Endpoint in Neutrophil Counts
Time frame: Baseline, 26 weeks
Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
Time frame: Baseline, 26 weeks
Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
8 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 LY2439821 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 8 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 8 inclusion and 21 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 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 26 May 2016). 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 Clinically Significant Effects (time frame: Baseline up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2016.