Arthritis, RheumatoidPhase 2NCT00308282

A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis

A Phase 2 study testing LY2127399 in people with Arthritis, Rheumatoid, run by Eli Lilly and Company at 14 sites in Romania.

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

This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. 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?: LY2127399
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 136 participants
Where: 14 sitesRomania
Study dates: 28 Mar 2006to 18 Oct 2007
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

Male or female between the ages of 18 and 75 years
Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
Current, regular use of Methotrexate, at a stable dose
Biologic DMARD naïve, and have had an insufficient response (in the opinion of the investigator) to an adequate therapeutic dose of at least 1 oral DMARD

Who cannot join

Use of excluded medications (reviewed by study doctor)
Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
Are unable to ambulate; that is, confined to bed or wheelchair bound
Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Romania14 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.
Bacau, 600114
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.
Baia Mare, 430031
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.
Brăila, 810217
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.
Brasov, 500365
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.
Bucharest, 024092
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.
Cluj-Napoca, 400006
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.
Constanța, 900607
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.
Craiova, 200322
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.
Iași, 707061
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.
Sf. Gheorghe, 520064
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.
Sibiu, 550245
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.
Targoviste, 130083
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.
Târgu Mureş, 540136
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.
Timișoara, 300002

Other trials in Romania

About this study

Official title: Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate

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

What participants receive

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

LY2127399Drug
30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
PlaceboDrug
IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.

Study groups in NCT00308282
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: LY2127399
B	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).
Measured: Week 16

Secondary outcomes (7)

Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms)
Treatment-emergent adverse events (TEAEs) were defined as those AEs with start date and time equal to or after the start of study medication infusion. In the case of a missing onset time for an AE, an AE with a start date equal to or greater than the dosing date was considered treatment-emergent. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received.
Measured: Baseline through Study Completion (Up to 19 Months)
Evaluation of the Pharmacokinetics of LY2127399: Clearance
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Measured: 2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose
Percentage of Participants Achieving ACR 50 and ACR70
ACR Responder Index: composite of clinical, laboratory, and functional measures of Rheumatoid Arthritis (RA). ACR50 and ACR70 Responder: had either a ≥50% or ≥70% improvement from baseline in both tender and swollen joint counts and either a ≥50% or ≥70% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP (respectively).
Measured: Baseline through Week 24
Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A negative change indicated an improvement.
Measured: Baseline, Week 24
European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses
EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders (NR) based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.
Measured: Baseline, Week 24
Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM
Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. A negative change indicates a decrease in Ig levels.
Measured: Baseline, Week 24
Change From Baseline in CD20+ B Cell Number Count
CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of Rheumatoid Arthritis (RA). A reduction in CD20+ B-cell values may indicate an improvement in RA symptoms.
Measured: Baseline, Week 24

Timeline

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

28 Mar 200618 Oct 2007

First posted29 Mar 2006 (estimated)
Study start28 Mar 2006
Primary completion18 Jun 2007
Study completion18 Oct 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00308282
Sponsor's protocol ID: 11055
Other IDs: H9B-MC-BCDF
Status last verified: Aug 2019
First submitted: 28 Mar 2006
Last updated: 10 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Genovese MC, Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L, Sloan-Lancaster J. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2013 Apr;65(4):880-9. doi: 10.1002/art.37820.
PubMed 23359344

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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate
ClinicalTrials.gov ID: NCT00308282
Acronym / sponsor ID: 11055
Conditions: Arthritis, Rheumatoid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 28 Mar 2006 (actual)
Primary completion: 18 Jun 2007 (actual)
Study completion: 18 Oct 2007 (actual)
First posted: 29 Mar 2006 (estimated)
Results: Posted 18 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: LY2127399
B	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (7 listed)

Male or female between the ages of 18 and 75 years
Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr

Key exclusion criteria (5 listed)

Use of excluded medications (reviewed by study doctor)
Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
Are unable to ambulate; that is, confined to bed or wheelchair bound
Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation.

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
LY212739930 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.	Drug	A
PlaceboIV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.	Drug	B

Primary outcome

Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)
Time frame: Week 16
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).

7 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms)
Time frame: Baseline through Study Completion (Up to 19 Months)
Evaluation of the Pharmacokinetics of LY2127399: Clearance
Time frame: 2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose
Percentage of Participants Achieving ACR 50 and ACR70
Time frame: Baseline through Week 24
Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP)
Time frame: Baseline, Week 24
European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses
Time frame: Baseline, Week 24
Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM
Time frame: Baseline, Week 24
Change From Baseline in CD20+ B Cell Number Count
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 18 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	34	31
30 mg LY2127399	34	30
60 mg LY2127399	34	33
160 mg LY2127399	34	32

Primary outcome: Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)

Time frame: Week 16. Number. Unit: percentage of participants

Measure	Placebo n = 34	30 mg LY2127399 n = 33	60 mg LY2127399 n = 34	160 mg LY2127399 n = 33
Value	29.4	57.6	67.6	51.5

Population analysed: All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 33 (9.1%)	15 of 33 (45.5%)	Not reported
30 mg LY2127399	2 of 34 (5.9%)	14 of 34 (41.2%)	Not reported
60 mg LY2127399	0 of 35 (0%)	15 of 35 (42.9%)	Not reported
160 mg LY2127399	3 of 34 (8.8%)	15 of 34 (44.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23359344Genovese MC, Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L, Sloan-Lancaster J. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2013 Apr;65(4):880-9. doi: 10.1002/art.37820.
Lilly Clinical Trial RegistryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2127399 in people with Arthritis, Rheumatoid, run by Eli Lilly and Company at 14 sites in Romania.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 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 Sep 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 Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 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?

Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale) (time frame: Week 16). 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 NCT00308282, 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 Sep 2019.