A Rheumatoid Arthritis study in patients

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002423

Enrollment

1505

Registered

2012-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Rheumatoid Arthritis

Interventions

Intervention1: 120 mg of LY2127399: Given every 4 weeks for 240 weeks for those patients from Study BCDO or Study BCDV. Patients who had been receiving placebo immediately prior to enrollment will rec

Eligibility

Inclusion criteria

Inclusion criteria: -Completion of 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM -Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion criteria

Exclusion criteria: -Current symptoms of a serious disorder or illness

Design outcomes

Primary

Measure	Time frame
-Percentage of patients developing anti-LY2127399 antibodies -Change from baseline in absolute B cell counts -Change from baseline in serum immunoglobulin (Ig) levelsTimepoint: Baseline through 240 weeks	—

Secondary

Measure	Time frame
Change from baseline in CRPTimepoint: Baseline through 240 weeks;Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP)Timepoint: Baseline through 240 weeks;Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DITimepoint: Baseline through 240 weeks;Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scoresTimepoint: Baseline through 240 weeks;Change from baseline in Patients Assessment of Pain (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Patients Global Assessment of Disease Activity (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Physicians Global Assessment of Disease Activity (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Swollen Joint Count (66 joint count)Timepoint: Baseline through 240 weeks;Change from baseline in Tender Joint Count (68 joint count)Timepoint: Baseline through 240 weeks;Mean percent improvement in ACR-NTimepoint: Baseline through 240 weeks;Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) responseTimepoint: Baseline through 240 weeks;Percentage of patients with DAS28-Based European League Against RheumatismTimepoint: Baseline through 240 weeks	—

Measure

Time frame

Change from baseline in CRPTimepoint: Baseline through 240 weeks;Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP)Timepoint: Baseline through 240 weeks;Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DITimepoint: Baseline through 240 weeks;Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scoresTimepoint: Baseline through 240 weeks;Change from baseline in Patients Assessment of Pain (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Patients Global Assessment of Disease Activity (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Physicians Global Assessment of Disease Activity (VAS)Timepoint: Baseline through 240 weeks;Change from baseline in Swollen Joint Count (66 joint count)Timepoint: Baseline through 240 weeks;Change from baseline in Tender Joint Count (68 joint count)Timepoint: Baseline through 240 weeks;Mean percent improvement in ACR-NTimepoint: Baseline through 240 weeks;Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) responseTimepoint: Baseline through 240 weeks;Percentage of patients with DAS28-Based European League Against RheumatismTimepoint: Baseline through 240 weeks

—

Countries

Argentina, Australia, Brazil, Bulgaria, Colombia, Croatia, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Malaysia, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Ukraine, United States of America

Contacts

Public ContactAnil Seth

Eli Lilly and Company India Pvt. Ltd.

seth_anil@lilly.com0124-4753000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026