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

NCT01955733 | Terminated Phase 3 Results

• 2 other identifiers: 1301.42013-002622-23
• Study Type: interventional
• Target: 91
• Locations: 9 countries
• Sites: 43

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase

  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.

  Week 48

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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

Study Arms (1)

BI 695500

EXPERIMENTAL

BI 695500, Two infusions separated by 2 weeks, Intravenous infusion

Drug: BI 695500

Interventions

BI 695500 DRUG

BI 695500

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must give written informed consent and be willing to follow this Clinical Trial Protocol.
• Male or female patients, with moderately to severely active RA who have previously participated in the double-blind randomized clinical Trial 1301.1.
• Current treatment for RA on an outpatient basis:
• Patients must continue to receive and tolerate oral or parenteral methotrexate (MTX) therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose).
• Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folinic acid (at least 1 mg per week or as per local practice) or equivalent during the entire trial.
• If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable.
• Intra-articular and parenteral corticosteroids are not permitted throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as part of the trial procedures.
• Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable throughout the trial.
• Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day, or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial.
• For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial, i.e., a combination of 2 forms of effective contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.). Females of childbearing potential must also agree to use an acceptable method of contraception (see above) for 12 months following completion or discontinuation from the trial medication.

You may not qualify if:

• Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 10 mg/day prednisone or equivalent.
• Serious underlying medical conditions, which, per the investigator¿s discretion, could impair the ability of the patient to participate in the trial (including but not limited to ongoing severe infection, severe immunosuppression, severe heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
• Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.
• Patients who have significant cardiac disease, including but not limited to congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification; uncontrolled angina or arrhythmia; any uncontrolled or severe cardiovascular or cerebrovascular disease; or uncontrolled hypertension.
• Treatment with IV or intramuscular corticosteroids. The only exception will be the administration of 100 mg IV methylprednisolone 30 to 60 minutes before each infusion as part of the trial procedures.
• Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times upper limit of normal (ULN).
• Hemoglobin \<8.0 g/dL.
• Levels of Immunoglobulin G(IgG) \<5.0 g/L.
• Absolute neutrophil count \<1500/µL.
• Platelet count \<75000/µL.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (43)

1301.4.5585 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1301.4.5727 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Location

1301.4.5725 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1301.4.5761 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

1301.4.5765 Boehringer Ingelheim Investigational Site

El Cajon, California, United States

Location

1301.4.5553 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Location

1301.4.5527 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1301.4.5771 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1301.4.5797 Boehringer Ingelheim Investigational Site

Santa Maria, California, United States

Location

1301.4.5807 Boehringer Ingelheim Investigational Site

Upland, California, United States

Location

1301.4.5809 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1301.4.5567 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1301.4.5561 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1301.4.5721 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Location

1301.4.5811 Boehringer Ingelheim Investigational Site

Cumberland, Maryland, United States

Location

1301.4.5507 Boehringer Ingelheim Investigational Site

Worcester, Massachusetts, United States

Location

1301.4.5715 Boehringer Ingelheim Investigational Site

Grand Rapids, Michigan, United States

Location

1301.4.5787 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1301.4.5525 Boehringer Ingelheim Investigational Site

Toms River, New Jersey, United States

Location

1301.4.5779 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

1301.4.5717 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1301.4.5801 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1301.4.5549 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1301.4.5729 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

1301.4.5757 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

1301.4.5789 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

1301.4.5705 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1301.4.5597 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Location

1301.4.5795 Boehringer Ingelheim Investigational Site

Beckley, West Virginia, United States

Location

1301.4.0303 Boehringer Ingelheim Investigational Site

Kortrijk, Belgium

Location

1301.4.0609 Boehringer Ingelheim Investigational Site

Plovdiv, Bulgaria

Location

1301.4.1705 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

1301.4.1807 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1301.4.3305 Boehringer Ingelheim Investigational Site

Sneek, Netherlands

Location

1301.4.3909 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1301.4.3907 Boehringer Ingelheim Investigational Site

Bydgoszcz, Poland

Location

1301.4.3915 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1301.4.3919 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1301.4.3917 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

1301.4.4013 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

1301.4.4007 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1301.4.4809 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1301.4.4813 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Further development of BI 695500 has been stopped and the program was therefore prematurely discontinued on 03Sep2015. The decision was made by the Sponsor based on a strategic review of company's product portfolio and not due to any safety concern.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 7, 2013
• Study Start: May 31, 2013
• Primary Completion: November 18, 2015
• Study Completion: November 7, 2016
• Last Updated: January 18, 2018
• Results First Posted: January 18, 2018

Record last verified: 2017-12

Locations

BE (1); BU (1); PL (5); DE (1); US (29); PT (2); ES (2); NL (1); GR (1)