Arthritis, Rheumatoid Clinical Trial
Official title:
A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.
This is a randomized (treatment assigned by chance, like flipping a coin), multicenter, double-blind (neither physician nor patient will know the treatment the patient receives), parallel-group (each group of patients will be treated at the same time) study. JNJ-40346527 will be compared to a placebo, which is an inactive substance used to test whether a drug has a real effect. Patients will receive study medication for 12 weeks and will continue their permitted, stable DMARD therapy (methotrexate [MTX], sulfasalazine [SSZ], and/or hydroxychloroquine [HCQ]) through Week 12. A follow-up visit will occur 4 weeks after dosing is complete. The maximum length of patient participation will be 22 weeks, including a 6-week screening period. Other study visits will occur during the study, and patient safety will be monitored. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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 |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
| 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 | |
| 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 |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
| 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 |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 | |
| Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 |