Phase 2
Completed N=158
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
Source: ClinicalTrials.gov NCT00785928 ↗Enrolled (actual)
158
Serious AEs
8.3%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks — 18.1; 17.7; 17.0; 15.0 percentage of participants — p=0.059
Summary
To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks |
18.1; 17.7; 17.0; 15.0; 11.8; 11.8 | 0.059 |
| SECONDARY Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks |
43.2; 43.6; 44.3; 46.9; 53.5; 61.5 | 0.044 sig |
| SECONDARY Change From Baseline in the Tender Joint Count up to 24 Weeks |
-7.1; -7.3; -4.5; -8.7; -7.8; -7.4 | 0.623 |
| SECONDARY Change From Baseline in Swollen Joint Count up to 24 Weeks |
-5.6; -6.9; -5.7; -8.9; -5.4; -6.2 | 0.671 |
| SECONDARY Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks |
-1.448; -1.539; -1.026; -1.678; -1.536; -1.642 | 0.457 |
| SECONDARY Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks |
11.4; 10.7; 10.5; 7.1; 23.5; 25.0 | 0.875 |
| SECONDARY Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks |
-19.5; -17.8; -12.8; -21.2; -13.1; -17.6 | 0.746 |
| SECONDARY Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks |
-23.7; -21.2; -16.1; -22.5; -19.3; -15.5 | 0.583 |
| SECONDARY Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks |
-22.8; -22.8; -26.3; -30.2; -28.3; -21.4 | 0.969 |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks |
-0.281; -0.288; -0.206; -0.258; -0.292; -0.587 | 0.880 |
| SECONDARY Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks |
9.13; 18.28; 93.75; 5.60; 24.17; -34.42 | 0.952 |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks |
4.4; 3.9; 3.8; 8.1; 6.9; 8.0 | 0.833 |
| SECONDARY Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks |
4.284; 3.422; 2.534; 5.584; 3.680; 9.487 | 0.562 |
| SECONDARY Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks |
0.0100; 0.0400; 0.270; 1.94; 5.16; 11.9 | — |
| SECONDARY Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks |
7.07; 7.94; 9.76; 15.9; 19.5; 21.6 | — |
| SECONDARY Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks |
17.63; -18.77; -50.85; -36.87; -68.59; -11.15 | 0.236 |
| SECONDARY Change From Baseline in Serum Immunoglobulin up to 24 Weeks |
-0.12; -0.14; -0.45; -0.45; -1.06; -0.93 | 0.901 |
| SECONDARY Number of Participants Experiencing An Adverse Event |
5; 4; 0; 0; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis (RA)
- Current, regular use of Methotrexate, at a stable dose
- Other criteria to be reviewed by study doctor
Exclusion Criteria
- Use of excluded medications(reviewed by study doctor)
- Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
- Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
- Evidence of tuberculosis
- Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
- Other criteria to be reviewed by study doctor
Data sourced from ClinicalTrials.gov (NCT00785928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.