A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: LY2189102Drug: placebo
- Registration Number
- NCT00380744
- Lead Sponsor
- Eli Lilly and Company
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- diagnosis of rheumatoid arthritis
- regular use of methotrexate
- active rheumatoid arthritis
- Juvenile Rheumatoid Arthritis
- evidence of tuberculosis
- women who are pregnant or become pregnant during study, or are breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A LY2189102 0.1 mg/kg/wk LY2189102 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 Part A LY2189102 0.3 mg/kg/wk LY2189102 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 Part A LY2189102 1.0 mg/kg/wk LY2189102 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 Part A LY2189102 2.5 mg/kg/wk LY2189102 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 Placebo placebo IV, once weekly x 4 wks
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) 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.
- Secondary Outcome Measures
Name Time Method 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 Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time) 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);Change From Baseline in Simple Disease Activity Index Score (SDAI) Baseline, Days 7, 21, 35, 63, and 98 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.
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28) Baseline, Days 7, 21, 35, 63, and 98 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.Change From Baseline in C-Reactive Protein (CRP) Baseline, Days 7, 14, 21, 28, 35, 63, and 98 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.
Change From Baseline in Health Assessment Questionnaire (HAQ) Score Baseline, Days 35, 63, and 98 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.
Trial Locations
- Locations (1)
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, Poland