Clinical Trials List
2012-11-05 - 2015-12-31
Phase III
Terminated10
Study ended1
ICD-10M05.70
Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement
ICD-10M05.711
Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement
ICD-10M05.712
Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement
ICD-10M05.719
Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement
ICD-10M05.721
Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement
ICD-10M05.722
Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement
ICD-10M05.729
Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement
ICD-10M05.731
Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement
ICD-10M05.732
Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement
ICD-10M05.739
Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement
ICD-10M05.741
Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement
ICD-10M05.742
Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement
ICD-10M05.749
Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement
ICD-10M05.751
Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement
ICD-10M05.752
Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement
ICD-10M05.759
Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement
ICD-10M05.761
Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement
ICD-10M05.762
Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement
ICD-10M05.769
Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement
ICD-10M05.771
Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement
ICD-10M05.772
Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement
ICD-10M05.779
Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement
ICD-10M05.79
Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement
ICD-10M05.80
Other rheumatoid arthritis with rheumatoid factor of unspecified site
ICD-10M05.811
Other rheumatoid arthritis with rheumatoid factor of right shoulder
ICD-10M05.812
Other rheumatoid arthritis with rheumatoid factor of left shoulder
ICD-10M05.819
Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder
ICD-10M05.821
Other rheumatoid arthritis with rheumatoid factor of right elbow
ICD-10M05.822
Other rheumatoid arthritis with rheumatoid factor of left elbow
ICD-10M05.829
Other rheumatoid arthritis with rheumatoid factor of unspecified elbow
ICD-10M05.831
Other rheumatoid arthritis with rheumatoid factor of right wrist
ICD-10M05.832
Other rheumatoid arthritis with rheumatoid factor of left wrist
ICD-10M05.839
Other rheumatoid arthritis with rheumatoid factor of unspecified wrist
ICD-10M05.841
Other rheumatoid arthritis with rheumatoid factor of right hand
ICD-10M05.842
Other rheumatoid arthritis with rheumatoid factor of left hand
ICD-10M05.849
Other rheumatoid arthritis with rheumatoid factor of unspecified hand
ICD-10M05.851
Other rheumatoid arthritis with rheumatoid factor of right hip
ICD-10M05.852
Other rheumatoid arthritis with rheumatoid factor of left hip
ICD-10M05.859
Other rheumatoid arthritis with rheumatoid factor of unspecified hip
ICD-10M05.861
Other rheumatoid arthritis with rheumatoid factor of right knee
ICD-10M05.862
Other rheumatoid arthritis with rheumatoid factor of left knee
ICD-10M05.869
Other rheumatoid arthritis with rheumatoid factor of unspecified knee
ICD-10M05.871
Other rheumatoid arthritis with rheumatoid factor of right ankle and foot
ICD-10M05.872
Other rheumatoid arthritis with rheumatoid factor of left ankle and foot
ICD-10M05.879
Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot
ICD-10M05.89
Other rheumatoid arthritis with rheumatoid factor of multiple sites
ICD-10M05.9
Rheumatoid arthritis with rheumatoid factor, unspecified
ICD-10M06.00
Rheumatoid arthritis without rheumatoid factor, unspecified site
ICD-10M06.011
Rheumatoid arthritis without rheumatoid factor, right shoulder
ICD-10M06.012
Rheumatoid arthritis without rheumatoid factor, left shoulder
ICD-10M06.019
Rheumatoid arthritis without rheumatoid factor, unspecified shoulder
ICD-10M06.021
Rheumatoid arthritis without rheumatoid factor, right elbow
ICD-10M06.022
Rheumatoid arthritis without rheumatoid factor, left elbow
ICD-10M06.029
Rheumatoid arthritis without rheumatoid factor, unspecified elbow
ICD-10M06.031
Rheumatoid arthritis without rheumatoid factor, right wrist
ICD-10M06.032
Rheumatoid arthritis without rheumatoid factor, left wrist
ICD-10M06.039
Rheumatoid arthritis without rheumatoid factor, unspecified wrist
ICD-10M06.041
Rheumatoid arthritis without rheumatoid factor, right hand
ICD-10M06.042
Rheumatoid arthritis without rheumatoid factor, left hand
ICD-10M06.049
Rheumatoid arthritis without rheumatoid factor, unspecified hand
ICD-10M06.051
Rheumatoid arthritis without rheumatoid factor, right hip
ICD-10M06.052
Rheumatoid arthritis without rheumatoid factor, left hip
ICD-10M06.059
Rheumatoid arthritis without rheumatoid factor, unspecified hip
ICD-10M06.061
Rheumatoid arthritis without rheumatoid factor, right knee
ICD-10M06.062
Rheumatoid arthritis without rheumatoid factor, left knee
ICD-10M06.069
Rheumatoid arthritis without rheumatoid factor, unspecified knee
ICD-10M06.071
Rheumatoid arthritis without rheumatoid factor, right ankle and foot
ICD-10M06.072
Rheumatoid arthritis without rheumatoid factor, left ankle and foot
ICD-10M06.079
Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot
ICD-10M06.08
Rheumatoid arthritis without rheumatoid factor, vertebrae
ICD-10M06.09
Rheumatoid arthritis without rheumatoid factor, multiple sites
ICD-10M06.1
Adult-onset Still's disease
ICD-10M06.20
Rheumatoid bursitis, unspecified site
ICD-10M06.211
Rheumatoid bursitis, right shoulder
ICD-10M06.212
Rheumatoid bursitis, left shoulder
ICD-10M06.219
Rheumatoid bursitis, unspecified shoulder
ICD-10M06.221
Rheumatoid bursitis, right elbow
ICD-10M06.222
Rheumatoid bursitis, left elbow
ICD-10M06.229
Rheumatoid bursitis, unspecified elbow
ICD-10M06.231
Rheumatoid bursitis, right wrist
ICD-10M06.232
Rheumatoid bursitis, left wrist
ICD-10M06.239
Rheumatoid bursitis, unspecified wrist
ICD-10M06.241
Rheumatoid bursitis, right hand
ICD-10M06.242
Rheumatoid bursitis, left hand
ICD-10M06.249
Rheumatoid bursitis, unspecified hand
ICD-10M06.251
Rheumatoid bursitis, right hip
ICD-10M06.252
Rheumatoid bursitis, left hip
ICD-10M06.259
Rheumatoid bursitis, unspecified hip
ICD-10M06.261
Rheumatoid bursitis, right knee
ICD-10M06.262
Rheumatoid bursitis, left knee
ICD-10M06.269
Rheumatoid bursitis, unspecified knee
ICD-10M06.271
Rheumatoid bursitis, right ankle and foot
ICD-10M06.272
Rheumatoid bursitis, left ankle and foot
ICD-10M06.279
Rheumatoid bursitis, unspecified ankle and foot
ICD-10M06.28
Rheumatoid bursitis, vertebrae
ICD-10M06.29
Rheumatoid bursitis, multiple sites
ICD-10M06.30
Rheumatoid nodule, unspecified site
ICD-10M06.311
Rheumatoid nodule, right shoulder
ICD-10M06.312
Rheumatoid nodule, left shoulder
ICD-10M06.319
Rheumatoid nodule, unspecified shoulder
ICD-10M06.321
Rheumatoid nodule, right elbow
ICD-10M06.322
Rheumatoid nodule, left elbow
ICD-10M06.329
Rheumatoid nodule, unspecified elbow
ICD-10M06.331
Rheumatoid nodule, right wrist
ICD-10M06.332
Rheumatoid nodule, left wrist
ICD-10M06.339
Rheumatoid nodule, unspecified wrist
ICD-10M06.341
Rheumatoid nodule, right hand
ICD-10M06.342
Rheumatoid nodule, left hand
ICD-10M06.349
Rheumatoid nodule, unspecified hand
ICD-10M06.351
Rheumatoid nodule, right hip
ICD-10M06.352
Rheumatoid nodule, left hip
ICD-10M06.359
Rheumatoid nodule, unspecified hip
ICD-10M06.361
Rheumatoid nodule, right knee
ICD-10M06.362
Rheumatoid nodule, left knee
ICD-10M06.369
Rheumatoid nodule, unspecified knee
ICD-10M06.371
Rheumatoid nodule, right ankle and foot
ICD-10M06.372
Rheumatoid nodule, left ankle and foot
ICD-10M06.379
Rheumatoid nodule, unspecified ankle and foot
ICD-10M06.38
Rheumatoid nodule, vertebrae
ICD-10M06.39
Rheumatoid nodule, multiple sites
ICD-10M06.80
Other specified rheumatoid arthritis, unspecified site
ICD-10M06.811
Other specified rheumatoid arthritis, right shoulder
ICD-10M06.812
Other specified rheumatoid arthritis, left shoulder
ICD-10M06.819
Other specified rheumatoid arthritis, unspecified shoulder
ICD-10M06.821
Other specified rheumatoid arthritis, right elbow
ICD-10M06.822
Other specified rheumatoid arthritis, left elbow
ICD-10M06.829
Other specified rheumatoid arthritis, unspecified elbow
ICD-10M06.831
Other specified rheumatoid arthritis, right wrist
ICD-10M06.832
Other specified rheumatoid arthritis, left wrist
ICD-10M06.839
Other specified rheumatoid arthritis, unspecified wrist
ICD-10M06.841
Other specified rheumatoid arthritis, right hand
ICD-10M06.842
Other specified rheumatoid arthritis, left hand
ICD-10M06.849
Other specified rheumatoid arthritis, unspecified hand
ICD-10M06.851
Other specified rheumatoid arthritis, right hip
ICD-10M06.852
Other specified rheumatoid arthritis, left hip
ICD-10M06.859
Other specified rheumatoid arthritis, unspecified hip
ICD-10M06.861
Other specified rheumatoid arthritis, right knee
ICD-10M06.862
Other specified rheumatoid arthritis, left knee
ICD-10M06.869
Other specified rheumatoid arthritis, unspecified knee
ICD-10M06.871
Other specified rheumatoid arthritis, right ankle and foot
ICD-10M06.872
Other specified rheumatoid arthritis, left ankle and foot
ICD-10M06.879
Other specified rheumatoid arthritis, unspecified ankle and foot
ICD-10M06.88
Other specified rheumatoid arthritis, vertebrae
ICD-10M06.89
Other specified rheumatoid arthritis, multiple sites
ICD-10M06.9
Rheumatoid arthritis, unspecified
ICD-9714.0
Rheumatoid arthritis
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 劉峰誠 風濕免疫科
- Tsung-Yun Hou 風濕免疫科
- 陳相成 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
[1] are at least 18 years of age
[2] have a diagnosis of adult-onset RA as defined by the ACR/EULAR 2010 Criteria for the Classification of RA (Aletaha et al. 2010)
[3] have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
a. If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC for entry or enrollment purposes.
[4] have a C-reactive protein (or hsCRP) measurement ≥1.2 times the upper limit of normal (ULN) based on the most recent data (if available)
[5] have had an insufficient response or are intolerant to cDMARDs and either:
a. have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
i. For patients treated with MTX, have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least 8 weeks prior to study entry. The dose of MTX is expected to
remain stable throughout the study and may be adjusted only for safety reasons.
1. For patients entering the trial on MTX doses <15 mg/week, there must be clear documentation in the medical record that higher doses of MTX were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines.
2. Local standard of care should be followed for concomitant administration of folic acid.
ii. For patients treated with the following DMARDs, have had regular use of them for at least the 12 weeks prior to study entry and a stable, nonchanging oral dose should have been administered for at least 8 weeks prior to study entry:
hydroxychloroquine up to 400 mg/day, sulfasalazine up to 3000 mg/day, leflunomide (Arava®, Sanofi-Aventis) up to 20 mg/day, and/or azathioprine up to 150 mg/day or 2 mg/kg/day.
b. For patients not receiving a cDMARD at the time of entry, the investigator will document in the patient’s history that the patient had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD.
[6] are able to read, understand, and give written informed consent
Exclusion Criteria
[7] are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
[8] have started treatment with NSAIDs (for which the NSAID use is intended for
treatment of signs and symptoms of RA) within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
[9] are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine
[10] have started a new physiotherapy treatment for RA in the 2 weeks prior to
study entry
[11] have ever received any biologic DMARD (such as TNF, interleukin-1 [IL-1],IL-6, or T-cell- or B-cell-targeted therapies)
[12] have received interferon therapy (such as Roferon-A, Intron-A, Rebetron, Alferon-N, Peg-Intron, Avonex, Betaseron, Infergen, Actimmune, and/or Pegasys) within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
[13] have received any parenteral corticosteroid administered by intramuscular or
intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
[14] have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization a. Joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization cannot be counted in the TJC or SJC for entry or enrollment purposes.
[15] have active fibromyalgia that, in the investigator’s opinion, would make it
difficult to appropriately assess RA activity for the purposes of this study
[16] have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn’s disease, ulcerative colitis, psoriatic arthritis, or active vasculitis
a. Patients with secondary Sjogren’s syndrome are not excluded.
[17] have a diagnosis of Felty’s syndrome
[18] have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the patient
[19] have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
[20] have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
[21] are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
[22] have an eGFR based on the most recent available serum creatinine using the
Modification of Diet in Renal Disease (MDRD) method of <40 mL/min/1.73 m2
[23] have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
[24] have, or have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
a. Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study.
b. Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study.
[25] have been exposed to a live vaccine within 12 weeks prior to planned
randomization or are expected to need/receive a live vaccine during the course
of the study (with the exception of herpes zoster vaccination)
a. All patients who have not received the herpes zoster vaccine at study entry will be encouraged to do so prior to randomization; vaccination must occur >30 days prior to randomization and start of study drug. Patients will be excluded if they were exposed to herpes zoster vaccination within 30 days of planned randomization.
b. Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study.
[26] have a current or recent (<30 days prior to study entry) clinically serious viral,
bacterial, fungal, or parasitic infection
[27] have had symptomatic herpes zoster infection within 12 weeks prior to study
entry
[28] have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
[29] are immunocompromised and, in the opinion of the investigator, are at an
unacceptable risk for participating in the study
[30] have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
[31] have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
[32] have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment
[33] are pregnant or nursing at the time of entry
[34] are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse while enrolled in the study and for at least 28 days following the last dose of investigational product
a. Females of nonchildbearing potential are defined as women ≥60 years of age, women ≥40 and <60 years of age who have had a cessation of menses for at least 12 months, or women who are congenitally or surgically sterile (that is, have had a hysterectomy or
bilateral oophorectomy or tubal ligation).
b. The following birth control methods are considered highly effective (the patient should choose 2 to be used with their partner):
oral, injectable, or implanted hormonal contraceptives condom with a spermicidal foam, gel, film, cream, or suppository occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository intrauterine device intrauterine system (for example, progestin-releasing coil) vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
[35] are males who do not agree to use 2 forms of highly effective birth control
(see above) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study, and for at least 28 days following the last dose of investigational product
[36] have donated >500 mL of blood within 30 days prior to study entry or intend to donate blood during the course of the study
[37] have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within the 2 years prior to study entry
[38] have previously been randomized in this study or any other study investigating baricitinib
[39] are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions and procedures
[40] have received prior treatment with an oral JAK inhibitor
[41] are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted
[42] are Lilly or Incyte employees or either’s designee
[43] are currently enrolled in or discontinued within 30 days of study entry from a
clinical trial involving an investigational product or nonapproved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
The Estimated Number of Participants
-
Taiwan
80 participants
-
Global
970 participants
