Clinical trials: Inadequate Response
Axial Psoratic Arthritis
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal…
- Trial name
- MAXIMISE (NCT02721966)
- Testing
- Secukinumab
- Where
- 94 sites in Belgium, Bulgaria and 16 more
- Volunteers
- 503 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of…
- Trial name
- NCT02349451
- Testing
- adalimumab, ABT-122
- Volunteers
- 240 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α…
- Trial name
- REASSURE (NCT01377012)
- Testing
- Secukinumab (AIN457)
- Where
- 142 sites in United States, Argentina and 14 more
- Volunteers
- 637 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate…
- Trial name
- LADYBUG (NCT04577781)
- Testing
- GLPG3970
- Where
- 9 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 28 people
- Sponsor
- Lakefront Biotherapeutics NV
Major Depressive Disorder
ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate…
- Trial name
- NCT01457677
- Testing
- RO4995819
- Where
- 92 sites in United States, Austria and 6 more
- Volunteers
- 357 people
- Sponsor
- Hoffmann-La Roche
Urticaria
Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).
- Trial name
- TAHOE (NCT00886795)
- Testing
- abatacept (Orencia ®)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Rheumatoid Arthritis
A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.
This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in…
- Trial name
- NCT02011334
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 25 sites in Argentina, Brazil and 4 more
- Volunteers
- 285 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks.
- Trial name
- NCT01211249
- Testing
- GLPG0259 oral capsule, GLPG0259 (Part B)
- Where
- 32 sites in Belgium, Netherlands and 3 more
- Volunteers
- 30 people
- Sponsor
- Lakefront Biotherapeutics NV
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
A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult…
- Trial name
- RESOLVE (NCT05604885)
- Testing
- AP1189, 60 mg, AP1189, 80 mg, AP1189, 100 mg
- Where
- Moldova
- Volunteers
- 125 people
- Sponsor
- SynAct Pharma Aps
Primary Biliary Cholangitis
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid…
- Trial name
- NCT07282353
- Testing
- 2mg CS0159
- Where
- 42 sites in China
- Volunteers
- 135 people
- Sponsor
- Cascade Pharmaceuticals, Inc
Rheumatoid Arthritis
Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment
The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using…
- Trial name
- NCT05165771
- Testing
- GS-5718, Tofacitinib 5 mg
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Rheumatoid Arthritis
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American…
- Trial name
- FINCH 2 (NCT02873936)
- Testing
- Filgotinib, csDMARDs
- Where
- 104 sites in United States, Argentina and 13 more
- Volunteers
- 449 people
- Sponsor
- Gilead Sciences
Major Depressive Disorder
Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)
To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.
- Trial name
- ETS6103-003 (NCT02014363)
- Testing
- ETS6103 (low dose), ETS6103 (high dose), Amitriptyline
- Where
- United Kingdom
- Volunteers
- 164 people
- Sponsor
- e-Therapeutics PLC
Ulcerative Colitis
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- U-ASTOUND (NCT05782907)
- Testing
- Upadacitinib
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 122 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding.
- Trial name
- OSKIRA - 1 (NCT01197521)
- Testing
- fostamatinib
- Where
- 127 sites in United States, Argentina and 15 more
- Volunteers
- 923 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis (RA)
A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)
The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis…
- Trial name
- NCT03660059
- Testing
- Peficitinib, Plaebo, Disease-modifying antirheumatic drugs (DMARDs)
- Where
- 43 sites in China, South Korea and 1 more
- Volunteers
- 385 people
- Sponsor
- Astellas Pharma China, Inc.
Major Depressive Disorder
A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment…
- Trial name
- NCT03093025
- Testing
- TS-121 10 mg, TS-121 50 mg
- Where
- 22 sites in United States
- Volunteers
- 51 people
- Sponsor
- Taisho Pharmaceutical R&D Inc.
Rheumatoid Arthritis
Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis
Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven synergistic effects in patients with either lymphoma or autoimmune diseases.
- Trial name
- NCT01244958
- Testing
- Rituximab
- Where
- 45 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Frank Behrens