Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis

Phase 3

Terminated

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: BI 695500

• Registration Number: NCT01955733
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-07
• Primary Completion: 2015-11-18
• Study Completion: 2016-11-07
• Results First Submitted: 2017-10-27
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Results First Posted: 2018-01-18
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 695500	BI 695500	BI 695500, Two infusions separated by 2 weeks, Intravenous infusion

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase	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.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4	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.
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	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 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	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.
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	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.

Trial Locations

Locations (43)

1301.4.5585 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1301.4.5727 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

1301.4.5725 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1301.4.5761 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

1301.4.5765 Boehringer Ingelheim Investigational Site; 🇺🇸 El Cajon, California, United States

1301.4.5553 Boehringer Ingelheim Investigational Site; 🇺🇸 Lakewood, California, United States

1301.4.5527 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1301.4.5771 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1301.4.5797 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Maria, California, United States

1301.4.5807 Boehringer Ingelheim Investigational Site; 🇺🇸 Upland, California, United States

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