BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: BI 695501
Drug: US-licensed Humira®

Registration Number: NCT02137226

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Primary Objective:

The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®.

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 645

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 695501	BI 695501	one injection every 2 weeks for 48 weeks (25 injections in total)
US-licensed Humira®	US-licensed Humira®	one injection every 2 weeks for 48 weeks (25 injections in total)

Primary Outcome Measures

Name	Time	Method
The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12	Week 12	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)).The Full Analysis Set contained all enrolled patients who were randomized to trial drug and who received at least one dose of trial drug and had all efficacy measures relevant for the co-primary efficacy endpoints measured at baseline and at least once post- baseline.
The Proportion of Patients Meeting ACR20 Response Criteria at Week 24	Week 24	ACR20 at Week 12 and Week 24 are standard outcome criteria that are widely accepted for regulatory purposes to demonstrate efficacy in treating the signs and symptoms of Rheumatoid arthritis (RA). The proportion of patients meeting the ACR20 response criteria was assessed at Week 12 and Week 24 to provide a robust comparison with US-licensed Humira® data. 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 \[CRP\]).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24	Baseline, Week 12 and Week 24	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 * Ln (ESR) = natural logarithm of ESR * GH = General Health component of the DAS (patient's global assessment of disease activity). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Actual number of patient analysed (N) is mean number of subjects in the analysis set with DAS28(ESR) results computable across the multiply imputed data sets. It is 319.6, 317.1 for week 12 and 313.9, 315.1 for week 24 for BI 695501 and US-licensed Humira® respectively.
The Percentage of Patients With Investigator-assessed Drug-related Adverse Events (AEs) During the Treatment Phase	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. Overall results are presented from Day 1 up to Week 58 and are based on the initial randomization groups. The comparison therefore focuses on patients who received BI 695501 continuously versus patients who received Humira® continuously for the long term assessment of safety. One patient was initially treated with Humira and discontinued prior to Week 24. This patient was mistakenly re randomized to BI 695501 but not treated. For safety this was counted in Humira not re-randomized group (as treated), and for other analysis sets, this patient was counted in the Humira to BI 695501 group (as randomized).

Trial Locations

Locations (131): Pinnacle Research Group, LLC
🇺🇸
Anniston, Alabama, United States
Rheumatology Associates
🇺🇸
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸
Phoenix, Arizona, United States
TriWest Research Associates, LLC
🇺🇸
El Cajon, California, United States
Advanced Medical Research, LLC
🇺🇸
La Palma, California, United States
ProHealth Partners
🇺🇸
Long Beach, California, United States
The Permanente Medical Group
🇺🇸
Santa Clara, California, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸
Upland, California, United States
Medvin Clinical Research
🇺🇸
Whittier, California, United States
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Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States