Clinical Trial to study effects of Baricitinib in Rheumatoid Arthritis patients with Inadequate Response to Conventional Drugs

Phase 3

Active, not recruiting

Conditions: Patients with Moderately to Severely Active Rheumatoid Arthritis

Registration Number: CTRI/2013/12/004212

Lead Sponsor: Eli Lilly and Company

Brief Summary: The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate response] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 660

Inclusion Criteria

Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA -Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints -Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement â‰¥ (greater than or equal to) 1.2 times the upper limit of normal (ULN) -Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either: 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 For participants not receiving a cDMARD at the time of entry, the investigator will document in the participants history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD.

Exclusion Criteria

Are currently receiving corticosteroids at doses (greater than)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 -Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization -Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs -Have ever received any biologic DMARD -Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study -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 -Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization -Have active fibromyalgia that, in the investigators opinion, would make it difficult to appropriately assess RA activity for the purposes of this study -Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis,spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with secondary Sjogrens syndrome are not excluded.) -Have a diagnosis of Feltys syndrome -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 participant -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 -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 -Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair -Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of (less than) 40 milliliter per minute per 1.73 m2 (mL/min/1.73 m2) -Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT)is greater than 1.5 times the ULN or the most recent available total bilirubin is greater than or equal to 1.5 times the ULN -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 less than 5 years -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) -Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection -Have had symptomatic herpes zoster infection within 12 weeks prior to study entry -Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia) -Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study -Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) -Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participants participation in the study Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participants participation in the study (eg, Fridericias corrected QT interval less than 500 millisecond [msec] for men and less than 520 msec for women) -Have symptomatic herpes simplex at the time of study enrollment -Have evidence of active or latent tuberculosis (TB).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving American College of Rheumatology 20 percent Improvement (ACR20)	Time Frame: Week 12

Secondary Outcome Measures

Name	Time	Method
-Change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	-Change from Baseline in the Disease Activity Score based on a 28-Joint Count (DAS-28)

Trial Locations

Locations (20): AMC MET Medical College and Seth LG General Hospital
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Ahmadabad, GUJARAT, India
AMRITA Institute of Medical Sciences and Research Centre
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Ernakulam, KERALA, India
Apollo Gleneagles Hospitals
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Kolkata, WEST BENGAL, India
Chanre Rheumatology & Immunology Centre for Research
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Bangalore, KARNATAKA, India
Gurunanak Care Hospital
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Hyderabad, ANDHRA PRADESH, India
Indraprastha Apollo Hospitals
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East, DELHI, India
Institute of Postgraduate Medical Education and Research
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Kolkata, WEST BENGAL, India
King George Medical College
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Lucknow, UTTAR PRADESH, India
KLES Prabhakar Kore Hospital and Medical Research Centre
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Belgaum, KARNATAKA, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
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Mumbai, MAHARASHTRA, India
Scroll for more (10 remaining)
AMC MET Medical College and Seth LG General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Piyush Parikh
Principal investigator
079-25472101
pnparikhlg@gmail.com