Clinical trials: Immune Surveillance
Rheumatoid Arthritis
A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia
An observational, non-interventional study on social, economic and quality-of-life outcomes of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.
- Trial name
- RELIVE (NCT01387789)
- Where
- 13 sites in Malaysia
- Volunteers
- 71 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
- Trial name
- NCT03219723
- Testing
- Vonoprazan, Amoxicillin hydrate, Clarithromycin
- Where
- Japan
- Volunteers
- 560 people
- Sponsor
- Takeda
Polyarticular Juvenile Idiopathic Arthritis
Surveillance of Humira in Korean JIA Patients
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT02141984
- Volunteers
- 28 people
- Sponsor
- AbbVie
Hematologic Malignancy
Besponsa Post Marketing Surveillance Study
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS.
- Trial name
- NCT04307134
- Testing
- Inotuzumab ozogamicin
- Where
- South Korea
- Volunteers
- 108 people
- Sponsor
- Pfizer
Ulcerative Colitis
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following…
- Trial name
- NCT04071405
- Testing
- Non-intervention
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
Chronic Hepatitis C, Hepatitis C
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus…
- Conditions
- Chronic Hepatitis C, Hepatitis C, HIV Infections
- Trial name
- NCT00736242
- Testing
- PEG-IFN alfa-2b, RBV
- Volunteers
- 232 people
- Sponsor
- Merck Sharp & Dohme LLC
Juvenile Idiopathic Arthritis
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA. 1.
- Trial name
- Enbrel-JIA (NCT01145352)
- Testing
- Etanercept (genetical recombination)
- Where
- Japan
- Volunteers
- 113 people
- Sponsor
- Pfizer
Spondylitis, Ankylosing, Arthritis, Rheumatoid
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.
- Conditions
- Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Arthritis, Psoriatic
- Trial name
- NCT00760669
- Testing
- Infliximab; observational study, Methotrexate; observational study
- Volunteers
- 1,061 people
- Sponsor
- Janssen Korea, Ltd., Korea
Rhinitis, Urticaria
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
- Trial name
- Aerius (NCT00724698)
- Testing
- Desloratadine
- Volunteers
- 3,011 people
- Sponsor
- Organon and Co
Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large…
- Trial name
- NCT02139592
- Testing
- Brentuximab vedotin (recombinant)
- Where
- Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
Asthma
Specific Use-Result of Spiriva Respimat® in Asthmatics
The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
- Trial name
- NCT03188120
- Testing
- Spiriva Respimat
- Where
- Japan
- Volunteers
- 193 people
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with…
- Trial name
- NCT02092467
- Testing
- tofacitinib, adalimumab, etanercept
- Where
- 345 sites in United States, Argentina and 28 more
- Volunteers
- 4,372 people
- Sponsor
- Pfizer
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Relapsed/Refractory Multiple Myeloma
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
- Trial name
- NCT03169361
- Testing
- Ixazomib
- Where
- Japan
- Volunteers
- 774 people
- Sponsor
- Takeda
Rheumatoid Arthritis
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives…
- Trial name
- NCT00503139
- Testing
- Enbrel (etanercept)
- Where
- Japan
- Volunteers
- 684 people
- Sponsor
- Pfizer
Arthritis, Rheumatoid, Spondylitis, Ankylosing
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists…
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis
- Trial name
- REMission (NCT00727298)
- Testing
- Infliximab
- Volunteers
- 4,485 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.
- Trial name
- NCT01932372
- Testing
- Tofacitinib (Xeljanz), Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
- Where
- Japan
- Volunteers
- 9,968 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients.
- Trial name
- NCT00195338
- Testing
- etanercept
- Where
- Luxembourg
- Volunteers
- 25 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s…
- Trial name
- NCT00195403
- Testing
- Etanercept
- Where
- 4 sites in South Korea
- Volunteers
- 1,014 people
- Sponsor
- Pfizer