Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT01955733|
Recruitment Status : Terminated (Substance discontinued)
First Posted : October 7, 2013
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: BI 695500||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial|
|Actual Study Start Date :||May 31, 2013|
|Actual Primary Completion Date :||November 18, 2015|
|Actual Study Completion Date :||November 7, 2016|
Experimental: BI 695500
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
Drug: BI 695500
- The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase [ Time Frame: Week 48 ]This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study [1301.4] and prior to the last date of trial medication + 180 days [inclusive]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
- Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4 [ Time Frame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4. ]
DAS-28 (ESR)** is an index containing a 28-joint count for tenderness (TJC28), 28 joint count for swelling (SJC28), natural logarithm of ESR (inflammation) (Ln[ESR]) and a general health component (GH) which is the patient's global assessment of disease activity and was used to describe the severity of RA. The DAS28 (ESR) Score is calculated as:
DAS28(ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.70*ln(ESR) + 0.014*(GH). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.
The mean change from baseline (in clinical trial 1301.1) at Week 48 in the DAS28 (ESR) score is presented.
- The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4 [ Time Frame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4. ]
A subject has an ACR20 response if all of the following occur:
- a > 20% improvement in the swollen joint count (66 joints)
- a > 20% improvement in the tender joint count (68 joints)
- a > 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (CRP).
The number of subjects meeting the ACR20 response criteria at Week 48 is presented.
- The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4 [ Time Frame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4. ]
To meet the ACR/EULAR Remission criteria*, the subject needed to satisfy the following criteria:
- TCJ (68 joints) < 1
- SJC (66 joints) < 1
- CRP < 1 milligrams per decilitre
- patient global assessment < 10. The patient global assessment for the definition of ACR/EULAR Remission was defined with a visual analog scale in millimetres (0-100).** The number of subjects meeting the ACR/EULAR Remission definition at Week 48 is presented.
- The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4 [ Time Frame: Week 48 ]This outcome measure presents percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955733
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|