Arthritis, Rheumatoid Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms in Subjects With Rheumatoid Arthritis
The purpose of this study is to determine the efficacy and safety of TAK-783, once daily (QD), taken in combination with methotrexate in subjects with rheumatoid arthritis.
Rheumatoid arthritis affects approximately 1% of the adult population. It is a chronic,
progressive disease characterized by synovial inflammation. The resulting inflammation leads
to destruction of the synovium and surrounding joint tissues, which can result in cartilage
destruction, bone erosion and resultant loss of joint function. It is an autoimmune disorder
of unknown etiology and typically affects the joints of the hand, wrist, knee, and foot,
usually in a bilateral pattern. Symptoms experienced early in the disease process include
pain, swelling, and tenderness of affected joints. As the disease progresses, many patients
experience joint stiffness, weakness, fatigue, anorexia, and weight loss, and ultimately
tissue damage and joint destruction. The severity of symptoms varies widely, ranging from
annoyance to debilitation. Rheumatoid arthritis is a disease that primarily afflicts adults,
with women being affected more often than men. Because rheumatoid arthritis is both chronic
and destructive, it requires early diagnosis and aggressive treatment to minimize the
morbidity associated with its progression, which can lead to deterioration in physical
function and psychological and social well-being. The objectives of rheumatoid arthritis
therapy are to reduce inflammation and to decrease the progression of articular damage.
Disease-modifying antirheumatic drugs are used to accomplish these objectives.
During the past several years, rheumatologists have become increasingly aggressive in
initiating treatment with disease-modifying antirheumatic drugs early in the course of
rheumatoid arthritis in an attempt to prevent joint destruction. The gold standard of
therapy has been methotrexate, which has been shown to be efficacious and safe, and appears
to remain effective, even after many years of treatment. However, not all patients respond
to methotrexate, and even patients who do respond most frequently have only a partial
response (reduced signs and symptoms, but still active disease). As a result, many patients
are treated with 2 or more disease-modifying antirheumatic drugs at the same time.
More recently, biologics (biotechnology drugs) have been introduced in the armamentarium
against rheumatoid arthritis, based on an improved understanding of the role of the
proinflammatory mediators, TNF-alpha, interleukin-1, and interleukin-6 in rheumatoid
arthritis. Etanercept (Enbrel®), a soluble TNF-alpha type II receptor-human immunoglobulin
fusion protein administered subcutaneously twice a week, infliximab (Remicade®), a chimeric
human mouse monoclonal antibody against TNF-alpha, administered intravenously every 4 to 8
weeks along with weekly methotrexate, and adalimumab (Humira®), a human-derived recombinant
immunoglobulin monoclonal antibody, administered subcutaneously every other week, are
currently available for treatment of rheumatoid arthritis. They have demonstrated rapid and
substantial improvement in rheumatoid arthritis, presumably by preventing the actions of
TNF-alpha in the joint, thereby reducing the inflammatory and destructive consequences of
TNF-alpha. Etanercept and infliximab have been granted Food and Drug Administration (FDA)
approved indications for reducing signs and symptoms, inhibiting the progression of
structural damage and improving physical function of patients with moderately to severely
active rheumatoid arthritis. Adalimumab has been granted FDA approved indications for
reducing signs and symptoms and inhibiting the progression of structural damage, and
Anakinra (Kineret®), an interleukin-1 receptor antagonist administered subcutaneously daily,
received FDA approval for reducing signs and symptoms.
TAK-783 is being developed as an orally administered compound for the treatment of
rheumatoid arthritis. Total participation time for this study is 16 to 40 weeks. All
subjects will remain on a stable dose of methotrexate throughout the trial.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01682512 -
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT00539760 -
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03312465 -
Anatomical Shoulder Domelock System Study
|
||
Completed |
NCT01208181 -
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
|
Phase 3 | |
Completed |
NCT03254810 -
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT01711814 -
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
|
Phase 2 | |
Completed |
NCT03315494 -
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
|
Phase 1 | |
Withdrawn |
NCT03241446 -
Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
|
Phase 1 | |
Completed |
NCT02553018 -
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe
|
Phase 3 | |
Completed |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
Active, not recruiting |
NCT02260778 -
Treat-to-target in RA: Collaboration To Improve adOption and adhereNce
|
N/A | |
Completed |
NCT02569736 -
Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
|
||
Completed |
NCT01750931 -
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
|
Phase 2 | |
Not yet recruiting |
NCT01154647 -
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
|
N/A | |
Withdrawn |
NCT01204138 -
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
|
Phase 2 | |
Completed |
NCT00973479 -
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
|
Phase 3 | |
Completed |
NCT00975130 -
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
|
Phase 3 | |
Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 | |
Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 |