Arthritis, RheumatoidPhase 3NCT01955733
Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
A Phase 3 study testing BI 695500 in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 43 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- BI 695500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 31 May 2013to 7 Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
United States29 sites
1301.4.5795 Boehringer Ingelheim Investigational Site
Beckley, West Virginia
1301.4.5585 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1301.4.5779 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1301.4.5757 Boehringer Ingelheim Investigational Site
Carrollton, Texas
1301.4.5717 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1301.4.5561 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1301.4.5721 Boehringer Ingelheim Investigational Site
Columbia, Maryland
1301.4.5789 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
1301.4.5811 Boehringer Ingelheim Investigational Site
Cumberland, Maryland
1301.4.5801 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1301.4.5765 Boehringer Ingelheim Investigational Site
El Cajon, California
1301.4.5727 Boehringer Ingelheim Investigational Site
Glendale, Arizona
1301.4.5715 Boehringer Ingelheim Investigational Site
Grand Rapids, Michigan
1301.4.5705 Boehringer Ingelheim Investigational Site
Houston, Texas
1301.4.5553 Boehringer Ingelheim Investigational Site
Lakewood, California
1301.4.5761 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
1301.4.5527 Boehringer Ingelheim Investigational Site
Long Beach, California
1301.4.5597 Boehringer Ingelheim Investigational Site
McKinney, Texas
1301.4.5549 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1301.4.5729 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1301.4.5787 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1301.4.5809 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1301.4.5725 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1301.4.5771 Boehringer Ingelheim Investigational Site
San Diego, California
1301.4.5797 Boehringer Ingelheim Investigational Site
Santa Maria, California
1301.4.5567 Boehringer Ingelheim Investigational Site
Tampa, Florida
1301.4.5525 Boehringer Ingelheim Investigational Site
Toms River, New Jersey
1301.4.5807 Boehringer Ingelheim Investigational Site
Upland, California
1301.4.5507 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts
Poland5 sites
1301.4.3909 Boehringer Ingelheim Investigational Site
Bialystok
1301.4.3907 Boehringer Ingelheim Investigational Site
Bydgoszcz
1301.4.3915 Boehringer Ingelheim Investigational Site
Krakow
1301.4.3919 Boehringer Ingelheim Investigational Site
Warsaw
1301.4.3917 Boehringer Ingelheim Investigational Site
Wroclaw
Portugal2 sites
1301.4.4013 Boehringer Ingelheim Investigational Site
Amadora
1301.4.4007 Boehringer Ingelheim Investigational Site
Lisbon
Spain2 sites
1301.4.4809 Boehringer Ingelheim Investigational Site
Seville
1301.4.4813 Boehringer Ingelheim Investigational Site
Seville
Netherlands1 site
1301.4.3305 Boehringer Ingelheim Investigational Site
Sneek
About this study
Official title: Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial
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
- Being tested
- BI 695500
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 695500Drug
| Study group | Role | What they receive |
|---|---|---|
| BI 695500 | Experimental | BI 695500, Two infusions separated by 2 weeks, Intravenous infusion Receives: Drug: BI 695500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study start31 May 2013
- Primary completion18 Nov 2015
- Study completion7 Nov 2016
Why it stopped: Substance discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955733
- Sponsor's protocol ID
- 1301.4
- Other IDs
- 2013-002622-23
- Status last verified
- Dec 2017
- First submitted
- 30 Sep 2013
- Last updated
- 18 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial
- ClinicalTrials.gov ID
- NCT01955733
- Acronym / sponsor ID
- 1301.4
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Substance discontinued
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 31 May 2013 (actual)
- Primary completion
- 18 Nov 2015 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 18 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 695500 | Experimental | Drug: BI 695500BI 695500, Two infusions separated by 2 weeks, Intravenous infusion |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 695500 | Drug | BI 695500 |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BI 695500 in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 43 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Poland, Portugal, Spain, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.