Clinical trials: Inadequate Response
Rheumatoid Arthritis
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to…
- Trial name
- NCT01960855
- Testing
- ABT-494
- Volunteers
- 276 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT 122 in subjects with active…
- Trial name
- NCT02141997
- Testing
- adalimumab, ABT-122
- Volunteers
- 222 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to…
- Trial name
- SELECT-NEXT (NCT02675426)
- Testing
- Upadacitinib
- Where
- 167 sites in United States, Argentina and 36 more
- Volunteers
- 661 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.
- Trial name
- CHS-0214-02 (NCT02115750)
- Testing
- Etanercept, CHS-0214
- Where
- 141 sites in United States, Belarus and 10 more
- Volunteers
- 647 people
- Sponsor
- Coherus Oncology, Inc.
Rheumatoid Arthritis
Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and…
- Trial name
- NCT01001832
- Testing
- Intravenous (IV) abatacept, Subcutaneous (SC) abatacept
- Where
- 33 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
Rheumatoid Arthritis
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD)…
- Trial name
- NCT00902486
- Testing
- INCB028050
- Where
- 49 sites in United States, Czechia
- Volunteers
- 127 people
- Sponsor
- Incyte Corporation
Rheumatoid Arthritis
A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis
This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease…
- Trial name
- OSCAR (NCT01987479)
- Testing
- Non-Biologic DMARDs, Tocilizumab, Methotrexate
- Where
- 20 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a…
- Trial name
- NCT01089023
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 9 sites in Bahrain, Iran and 3 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Gout
Combining Lesinurad With Allopurinol in Inadequate Responders
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to…
- Trial name
- CLEAR 2 (NCT01493531)
- Testing
- Lesinurad, Allopurinol
- Where
- 175 sites in United States, Australia and 9 more
- Volunteers
- 610 people
- Sponsor
- Ardea Biosciences, Inc.
Adjunctive Treatment of Major Depressive Disorder
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.
- Trial name
- NCT04000009
- Testing
- Pimavanserin
- Where
- 71 sites in United States, Finland and 7 more
- Volunteers
- 235 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Rheumatoid Arthritis
A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit.
- Trial name
- NCT00502840
- Testing
- rituximab [MabThera/Rituxan]
- Where
- 51 sites in Germany
- Volunteers
- 193 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT05470985
- Testing
- Ozanimod
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Plaque Psoriasis
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.
- Trial name
- NCT02547714
- Testing
- Secukinumab (AIN457)
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab
To determine the effectiveness of ACH-0144471 (also known as danicopan and ALXN2040) in improving anemia when given with eculizumab for 24 weeks in participants with PNH.
- Trial name
- PNH (NCT03472885)
- Testing
- Danicopan, Eculizumab
- Where
- 5 sites in United States, Italy and 1 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Arthritis, Rheumatoid
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy
This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period.
- Trial name
- NCT00603525
- Testing
- Ofatumumab
- Where
- 60 sites in Argentina, Denmark and 10 more
- Volunteers
- 169 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Psoriasis
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy.
- Trial name
- TRANSIT (NCT01059773)
- Testing
- Ustekinumab, Methotrexate
- Where
- 76 sites in Austria, Belgium and 17 more
- Volunteers
- 490 people
- Sponsor
- Janssen-Cilag International NV
Rheumatoid Arthritis
A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients…
- Trial name
- NCT01063062
- Testing
- tocilizumab [RoActemra/Actemra], Methotrexate
- Where
- 9 sites in Egypt
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche