Clinical Trials Logo
  1. Home
  2. Rheumatoid Arthritis (RA)
  3. NCT05421442
  4. Details
NCT05421442 Clinical Trial

A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

Rheumatoid Arthritis (RA) Clinical Trial

— DANBIO  

Official title:
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05421442
Other study ID # IM101-803
Secondary ID EUPAS31532
Status Active, not recruiting
Phase
First received
Last updated
Start date June 13, 2019
Est. completion date July 31, 2025

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1450
Est. completion date July 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA) - Receiving treatment with abatacept - Receiving treatment with non-targeted DMARD - Receiving treatment with targeted DMARD Exclusion Criteria: -Not applicable

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Local Institution Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Rates of Overall Malignancies Up to 5 years
Primary Incidence Rates of Melanoma Up to 5 years
Primary Incidence Rates of Non-melanoma Skin Cancer Up to 5 years
Primary Incidence Rates of Basal Cell Carcinoma Up to 5 years
Primary Incidence Rates of Squamous Cell Carcinoma Up to 5 years
See also
  Status Clinical Trial Phase
Completed NCT05047341 - A Study of Human Substance Balance and Biotransformation of [14C]SHR0302 Phase 1
Withdrawn NCT02786563 - Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
Completed NCT03257852 - A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate Phase 2
Completed NCT03660059 - 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) Phase 3
Recruiting NCT03971253 - Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Not yet recruiting NCT05486715 - Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
Completed NCT03682705 - A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis Phase 2
Active, not recruiting NCT04574492 - A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
Active, not recruiting NCT02805010 - Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously Phase 1
Completed NCT01871961 - Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient Phase 1
Active, not recruiting NCT04497597 - A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Terminated NCT02775656 - UCB Cimzia Pregnancy Follow-up Study
Completed NCT01173120 - Methotrexate - Inadequate Response Device Sub-Study Phase 3
Completed NCT03223012 - Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
Completed NCT03086343 - A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs Phase 3
Terminated NCT01569152 - Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008) Phase 2
Completed NCT02105129 - A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523 Phase 1
Completed NCT01577563 - Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS). N/A
Completed NCT01618968 - Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device Phase 2
Completed NCT01618955 - Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device Phase 2

External Links