Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02640612|
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:
- the change from Baseline in DAS28 (ESR) at Week 48
- the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48
- the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48
- the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: BI 695501||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab|
|Actual Study Start Date :||January 22, 2016|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
|Experimental: BI 695501||
Drug: BI 695501
- Percentage of Patients With Drug-related Adverse Events (AEs) During the Treatment Phase [ Time Frame: From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks. ]The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator.
- Change From Baseline in Disease Activity Score in 28 Joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at Week 48 [ Time Frame: Baseline and Week 48. ]The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component of the DAS (patient's global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of 1297.2. Improvement in DAS28 was also categorized using the European League Against Rheumatism (EULAR) response criteria. The DAS28 provides a number on a scale from 0 to 10 where higher values mean a higher disease activity. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
- Percentage of Patients Meeting American College of Rheumatology (ACR) 20% Response Criteria at Week 48 [ Time Frame: Week 48. ]The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: 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 three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).
- Percentage of Patients Who Meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) Definition of Remission at Week 48 [ Time Frame: Week 48. ]
The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following:
- Tender joint count (TJC) ≤ 1
- Swollen joint count (SJC) ≤ 1
- C-reactive protein (CRP) ≤ 1 mg/dL
- Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale) For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission.
- Percentage of Patients With European League Against Rheumatism (EULAR) Response (Good Response, Moderate Response, or no Response) at Week 48 [ Time Frame: Week 48. ]
Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 for assessment of this outcome measure.
No response: If improvement in DAS28 (ESR) at w48 <=0.6, or if DAS28(ESR) at w48 >5.1 and improvement is in range >0.6 to <1.2.
Moderate response: If DAS28(ESR) at w48 <=5.1 and improvement is in range >0.6 to <1.2, or, DAS28(ESR) at w48 >3.2 and improvement is in range >=1.2.
Good response: If DAS28(ESR) at w48 <=3.2 and improvement >=1.2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640612
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|