Clinical trials: Immune Responses
Rheumatoid Arthritis
ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.
- Trial name
- NCT05279417
- Testing
- ATI-450 50 mg oral tablet BID, Methotrexate, ATI-450 20 mg oral tablet BID
- Where
- 50 sites in United States, Bulgaria and 2 more
- Volunteers
- 251 people
- Sponsor
- Aclaris Therapeutics, Inc.
Rheumatoid Arthritis
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to…
- Trial name
- AUGUST II (NCT00595413)
- Testing
- Atacicept: with loading dose, Atacicept, Adalimumab
- Where
- 2 sites in United States, Germany
- Volunteers
- 311 people
- Sponsor
- EMD Serono
Lymphocytic Leukemia, Chronic
A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia.
- Trial name
- NCT01056510
- Testing
- bendamustine, chlorambucil, rituximab [MabThera/Rituxan]
- Where
- 85 sites in Finland, France and 6 more
- Volunteers
- 357 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 1
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab.
- Trial name
- NCT02000817
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed…
- Trial name
- NCT01018732
- Testing
- Novartis Meningococcal (MenACWY-CRM) vaccine
- Where
- 3 sites in United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
Lymphoma
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma.
- Trial name
- NCT00517699
- Testing
- rituximab [MabThera/Rituxan], Methotrexate, Cytarabine
- Where
- 2 sites in Canada
- Volunteers
- 5 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α…
- Trial name
- NCT01651936
- Testing
- MK-8457 100 mg, Methotrexate
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypersensitivity
The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of…
- Trial name
- NCT00359138
- Testing
- desloratadine, levocetirizine
- Volunteers
- 36 people
- Sponsor
- Organon and Co
Rheumatoid Arthritis
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with…
- Trial name
- NCT02706951
- Testing
- Methotrexate, Upadacitinib
- Where
- 153 sites in United States, Argentina and 23 more
- Volunteers
- 648 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
Systemic Lupus Erythematosus
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
- Trial name
- NCT02472795
- Testing
- Cenerimod
- Where
- 18 sites in United States, Belarus and 4 more
- Volunteers
- 105 people
- Sponsor
- Viatris Innovation GmbH
Rheumatoid Arthritis
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate…
- Trial name
- NCT01235507
- Testing
- methotrexate, tocilizumab [RoActemra/Actemra]
- Where
- 3 sites in Bosnia and Herzegovina
- Volunteers
- 71 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
- Trial name
- NCT00095147
- Testing
- Abatacept (ABA) + Methotrexate (MTX), double-blind (DB), Infliximab (INF) + MTX, DB, PLA + MTX switched to ABA+ MTX, DB
- Where
- 76 sites in United States, Argentina and 15 more
- Volunteers
- 431 people
- Sponsor
- Bristol-Myers Squibb
Multiple Myeloma
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem…
- Trial name
- NCT03288493
- Testing
- P-BCMA-101 CAR-T cells, Rimiducid
- Where
- 16 sites in United States
- Volunteers
- 105 people
- Sponsor
- Poseida Therapeutics, Inc.
Inflammatory Bowel Disease
Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.
- Trial name
- NCT01981616
- Testing
- Vedolizumab, Hepatitis B vaccine, Oral cholera vaccine
- Where
- United Kingdom
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Relapsing-remitting Multiple Sclerosis
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and…
- Trial name
- NCT00879658
- Testing
- BAF312
- Where
- 72 sites in United States, Canada and 10 more
- Volunteers
- 297 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
- Trial name
- NCT00487825
- Testing
- Canakinumab (investigational), Methotrexate (MTX)
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 78 people
- Sponsor
- Novartis
Rheumatoid Arthritis
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50…
- Trial name
- NCT01894516
- Testing
- GLPG0634
- Where
- 82 sites in United States, Argentina and 17 more
- Volunteers
- 287 people
- Sponsor
- Lakefront Biotherapeutics NV