NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Rheumatoid Arthritis
Date of first enrollment	10/07/2017
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : LY3337641 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Part A: Low Dose, Mid Dose or High Dose LY3337641, administered orally, given once a day for 4 weeks.; Part B: Low Dose, Mid Dose or High Dose LY3337641, administered orally, given once a day for 12 weeks. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Part A: Placebo, administered orally, given once a day for 4 weeks.; Part B: Placebo, administered orally, given once a day for 12 weeks.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Inclusion Criteria: - Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed - Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential - Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy - Have a diagnosis of RA based on the 2010 ACR/European League against Rheumatism criteria - Have at least 1 of the following: -- rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR -- radiographs documenting bony erosions - Have active RA, defined as: -- Part A: >=3 swollen joints (based on 66-joint counts) -- Part B: --- >=6 swollen joints (based on 66-joint counts) --- >=6 tender joints (based on 68-joint counts) --- hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA - Part B only: Have had inadequate response, loss of response, or intolerance to at least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD) Exclusion Criteria: - Have received any of the following: -- Part B only: any prior treatment with a product directly targeting Bruton's tyrosine kinase (BTK) (marketed or investigational) -- belimumab, natalizumab, or vedolizumab within 6 months prior to baseline -- B-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) within 12 months prior to screening for Part A or at any time prior to screening for Part B - Have known hypogammaglobulinemia - Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus - Have active tuberculosis (TB) - Are at high risk of infection or have recent evidence of clinically significant infection - Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin - Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
Exclude criteria