AbbVie

This sponsor has funded 31 studies across 35 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
6213 Ongoing EU RMP category 3 A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (adalimumab) in Pediatric Patients with Moderately to Severely... Yes No
7196 Ongoing Not included in RMP Juvenile arthritis Methotrexate/Biologics long-term Observation (JuMBO) No No
7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No
13832 Finalised EU RMP category 3 Evaluation of the potential for and clinical impact of increased ALT in patients using the AbbVie 2-DAA or 3-DAA Regimens in a real world setting Yes Yes
15353 Ongoing EU RMP category 3 Linaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C Yes No
19010 Ongoing EU RMP category 3 Prospective observational study to assess the long term safety profile of venetoclax in a Swedish cohort of Chronic Lymphocytic Leukaemia (CLL)... Yes No
20918 Finalised Not included in RMP Advanced Parkinson’s disease treatment eligibility in France: an epidemiological study (EPIPARK) Yes Yes
21010 Ongoing EU RMP category 3 A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active... Yes No
24321 Ongoing EU RMP category 3 Injectors’ Survey to Assess Effectiveness of BELKYRA Risk Minimisation Activities Yes No
30560 Ongoing EU RMP category 3 A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)... Yes Yes
30576 Ongoing EU RMP category 3 A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in... Yes No
30818 Finalised EU RMP category 3 A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for... Yes Yes
32308 Finalised Not included in RMP Venetoclax (ABT-199) in Patients with Chronic Lymphocytic Leukemia: Experience through the Pre-Approval Access Program in European Countries: A... Yes Yes
32607 Finalised EU RMP category 3 European Pregnancy and Pediatric HIV Cohort Collaboration (EPPICC) study assessing the safety and efficacy of Kaletra oral solution in children aged... Yes Yes
36303 Ongoing Not included in RMP A prospective observational study to evaluate the clinical outcomes and burden of disease of PD patients with motor fluctuations not adequately... Yes No
36459 Finalised Not included in RMP A Cross-sectional and retrospective chart review study for assessing psoRiasis severitY by absolute PASI score in moderaTe to severe psoriatic... Yes Yes
39194 Ongoing EU RMP category 3 Long-term safety study of Rinvoq in RA patients enrolled in the Corrona RA Registry in the United States Yes No
39211 Ongoing EU RMP category 3 Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures Yes No
39217 Ongoing EU RMP category 3 Long-term comparative safety cohort studies of upadacitinib (Rinvoq™) use for the treatment of RA in Europe Yes No
39351 Ongoing EU RMP category 3 A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden Yes No
39656 Finalised Not included in RMP A Single-Arm Retrospective Study to Evaluate Safety and Efficacy in Patients with Acute Hepatitis C Virus (HCV) Infection Treated with 8 Weeks of... Yes Yes
39775 Ongoing EU RMP category 3 Pregnancy Exposures and Outcomes in Women with Psoriasis Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases... Yes No
41657 Finalised Not included in RMP Direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection and the risk of hepatocellular carcinoma (HCC)... Yes Yes
44830 Finalised Not included in RMP LICAVIR Study Synopsis and Table Shells Yes Yes
49230 Planned EU RMP category 3 Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden No No
104737 Planned EU RMP category 3 Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe Yes No
104768 Planned EU RMP category 3 Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe Yes No
106180 Planned EU RMP category 3 A study of growth, development and maturation in adolescents with atopic dermatitis who receive upadacitinib Yes No
107124 Planned EU RMP category 3 Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe No No
107322 Ongoing Not included in RMP Validation of the UC-IUS score No No
107885 Planned EU RMP category 3 Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe No No

PAS by Risk Management Plan (RMP) requirement

AbbVie

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.