Arthritis, RheumatoidPhase 1/2NCT00380744

A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

A Phase 1/2 study testing LY2189102 in people with Arthritis, Rheumatoid, run by Eli Lilly and Company at 14 sites in 2 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

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis. Part A of the study is an initial dose escalation phase Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: LY2189102
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 14 sitesin 2 countries
Study dates: Nov 2005to Nov 2007
Phase: Phase 1/2
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

diagnosis of rheumatoid arthritis
regular use of methotrexate
active rheumatoid arthritis

Who cannot join

Juvenile Rheumatoid Arthritis
evidence of tuberculosis
women who are pregnant or become pregnant during study, or are breast-feeding

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States10 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.
Albuquerque, New Mexico, 87102
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.
Bend, Oregon, 97701
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.
Mayfield, Ohio, 44143
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Meridian, Idaho, 83642
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Miami, Florida, 33169
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Orangeburg, South Carolina, 29118
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Port Orange, Florida, 32127
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.
Tucson, Arizona, 85712
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.
Upland, California, 91786
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.
Vero Beach, Florida, 32962

Other trials in United States

Poland4 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.
Bialystok, 15 297
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.
Szczecin, 71-252
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.
Warsaw, 02-637
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.
Wroclaw, 53-137

Other trials in Poland

About this study

Official title: A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.

Part A of the study is an initial dose escalation phase

Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments

Conditions: Arthritis, Rheumatoid
Being tested: LY2189102, 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.

LY2189102Drug
placeboDrug

Study groups in NCT00380744
Study group	Role	What they receive
Part A LY2189102 0.1 mg/kg/wk	Experimental	Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV Receives: Drug: LY2189102
Part A LY2189102 0.3 mg/kg/wk	Experimental	Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV Receives: Drug: LY2189102
Part A LY2189102 1.0 mg/kg/wk	Experimental	Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Receives: Drug: LY2189102
Part A LY2189102 2.5 mg/kg/wk	Experimental	Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Receives: Drug: LY2189102
Placebo	Placebo comparator	IV, once weekly x 4 wks Receives: Drug: placebo

What is being measured

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

Number of Participants With Adverse Events (AEs)
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline up to Day 98

Secondary outcomes (5)

Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102
AUC0-168 hr,ss of individual participants was calculated by equation AUC=Dose/Clearance (CL), where the CL was estimated using a population PK model.
Time frame for Part B: Day 1 predose, immediately after infusion (IAI), Day 14 and 28: predose and IAI, and Day 63 (Convenient time);
Measured: Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)
Change From Baseline in Simple Disease Activity Index Score (SDAI)
SDAI is calculated as the sum of 5 components: tender joint count (TJC) and swollen joint count (SJC), Patient Global Assessment (PtGA) of disease activity visual analog scale (VAS) and Physician's Global Assessment of Disease Activity (PGA) VAS, and C-reactive protein (CRP). Total Score scale range is 0 (remission) to 86 (high disease activity). A negative change from baseline indicated an improvement. Least Squares (LS) mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.
Measured: Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
DAS28-4 (crp) is a modification of the original DAS based on TJC and SJC based on 28 joint counts, PGA VAS. DAS28-4 (crp) calculated as: 0.56*square root (sqrt) (TJC)+0.28*sqrt(SJC)+0.36*ln(CRP+1)+0.014*PGA+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. A decrease in DAS28-CRP indicated an improvement in participant's condition.
LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.
Measured: Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in C-Reactive Protein (CRP)
CRP is a biomarker associated with inflammation and structural damage. A negative change from baseline indicates improvement. LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.
Measured: Baseline, Days 7, 14, 21, 28, 35, 63, and 98
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
HAQ was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ score. If the participant had scores for fewer than 6 categories, the HAQ score was considered missing. The HAQ score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.
Measured: Baseline, Days 35, 63, and 98

Timeline

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

Nov 2005Nov 2007

First posted26 Sep 2006 (estimated)
Study startNov 2005
Primary completionNov 2007
Study completionNov 2007

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00380744
Sponsor's protocol ID: 8705
Other IDs: H9C-MC-BBDE
Status last verified: Aug 2018
First submitted: 22 Sep 2006
Last updated: 6 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.
PubMed 24912797

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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All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT00380744
Acronym / sponsor ID: 8705
Conditions: Arthritis, Rheumatoid
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 26 Sep 2006 (estimated)
Results: Posted 6 Feb 2019

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 examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.

Part A of the study is an initial dose escalation phase

Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Part A LY2189102 0.1 mg/kg/wk	Experimental	Drug: LY2189102Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV
Part A LY2189102 0.3 mg/kg/wk	Experimental	Drug: LY2189102Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV
Part A LY2189102 1.0 mg/kg/wk	Experimental	Drug: LY2189102Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV
Part A LY2189102 2.5 mg/kg/wk	Experimental	Drug: LY2189102Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV
Placebo	Placebo comparator	Drug: placeboIV, once weekly x 4 wks

Who may qualify

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

Key inclusion criteria (3 listed)

diagnosis of rheumatoid arthritis
regular use of methotrexate
active rheumatoid arthritis

Key exclusion criteria (3 listed)

Juvenile Rheumatoid Arthritis
evidence of tuberculosis
women who are pregnant or become pregnant during study, or are breast-feeding

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
LY2189102	Drug	Part A LY2189102 0.1 mg/kg/wk, Part A LY2189102 0.3 mg/kg/wk, Part A LY2189102 1.0 mg/kg/wk, Part A LY2189102 2.5 mg/kg/wk
placebo	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Day 98
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

5 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102
Time frame: Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Time frame: Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Time frame: Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in C-Reactive Protein (CRP)
Time frame: Baseline, Days 7, 14, 21, 28, 35, 63, and 98
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Time frame: Baseline, Days 35, 63, and 98

Results and safety

Results posted to the registry on 6 Feb 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
Part B - 0.02 mg/kg/wk LY2189102	20	19
Part A - 0.1 mg/kg/wk LY2189102	4	4
Part B - 0.15 mg/kg/wk LY2189102	20	20
Part A - 0.3 mg/kg/wk LY2189102	4	4
All Parts - 1.0 mg/kg/wk LY2189102	23	23
All Parts - 2.5 mg/kg/wk LY2189102	25	25
All Parts - Placebo	25	24

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to Day 98. Count of participants. Unit: Participants

Measure	0.02 mg/kg/wk LY2189102 n = 20	0.1 mg/kg/wk LY2189102 n = 4	0.15 mg/kg/wk LY2189102 n = 20	0.3 mg/kg/wk LY2189102 n = 4	1.0 mg/kg/wk LY2189102 n = 23	2.5 mg/kg/wk LY2189102 n = 25	Placebo n = 25
SAEs	0	0	0	0	0	1	2
Other Non-Serious AEs	8	4	10	4	7	11	14

Population analysed: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.02 mg/kg/wk LY2189102	0 of 20 (0%)	8 of 20 (40%)	Not reported
0.1 mg/kg/wk LY2189102	0 of 4 (0%)	4 of 4 (100%)	Not reported
0.15 mg/kg/wk LY2189102	0 of 20 (0%)	10 of 20 (50%)	Not reported
0.3 mg/kg/wk LY2189102	0 of 4 (0%)	4 of 4 (100%)	Not reported
1.0 mg/kg/wk LY2189102	0 of 23 (0%)	7 of 23 (30.4%)	Not reported
2.5 mg/kg/wk LY2189102	1 of 25 (4%)	11 of 25 (44%)	Not reported
Placebo	2 of 25 (8%)	14 of 25 (56%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24912797Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Arthritis, Rheumatoid

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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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R-2487 in Patients With Sjogren's Syndrome (SjD)
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A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LY2189102 in people with Arthritis, Rheumatoid, run by Eli Lilly and Company at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Poland. 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 combined 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.

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 Feb 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 Adverse Events (AEs) (time frame: Baseline up to Day 98). 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 NCT00380744, 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 Feb 2019.