Rheumatoid ArthritisPhase 2NCT01481493
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
A Phase 2 study testing BT061 in people with Rheumatoid Arthritis, run by Biotest at 39 sites in 7 countries.
Trial summary
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (MTX). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BT061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Dec 2010to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
- Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
- Duration of RA more than 12 month
- History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
- MTX treatment at least 6 month with a stable dose at least 15mg MTX
- Patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline
- Written Informed Consent
Who cannot join
- Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
- Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
- treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
- Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
Poland11 sites
Study Site (Bialystok 2)
Bialystok
Study Site
Bialystok
Study Site
Bydgoszcz
Study Site
Elblag
Study site
Gmina Końskie
Study Site
Krakow
Study Site
Lublin
Study Site
Poznan
Study Site
Torun
Study site
Warsaw
Study Site
Wroclaw
Italy8 sites
Study Site
Bari
Study Site
Cagliari
Study Site
Chieti
Study Site
Florence
Study Site
Genova
Study site
Milan
Study site
Padova
Study Site
Palermo
Spain7 sites
Study site (Barcelona 1)
Barcelona
Study site (Barcelona 2)
Barcelona
Study Site
Bilbao
Study Site (Madrid2)
Madrid
Study Site
Madrid
Study Site
Málaga
Study Site
Santander
Germany5 sites
Study Site (Berlin 1)
Berlin
Study Site (Berlin 2)
Berlin
Study Site
Erlangen
Study Site
Frankfurt
Study site
München
Czechia4 sites
Study Site
Ostrava
Study Site
Prague
Study Site
Uherské Hradiste
Study Site
Zlín
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (MTX).
Read the detailed description
Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a double-blind set-up.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BT061, Placebo
- Keywords
- rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT061Biological
Also called immune-modulatory antibody BT061
subcutaneous administration of the monoclonal antibody BT061
PlaceboBiological
Also called end formulation buffer without active ingredient
subcutaneous injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | BT061 monoclonal antibody (subcutaneous) Receives: Biological: BT061 |
| Placebo | Placebo comparator | subcutaneous injection of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-response information
ACR20 response (percentage of patients reaching or exceeding at least a 20% improvement in their arthritis assessment according to the criteria of the American College of Rheumatology)
Measured: ACR20 response at week 13 (1 week after last dose of study drug)
Secondary outcomes (3)
efficacy responses other than ACR20, including questionaires, and their dose dependencies
ACR50, ACR70, ESR, DAS28, CRP, HAQs, FACIT, RF, Hb,
Measured: weekly assessment of ACR arthritis status during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Safety and tolerability of the various dose levels and of placebo
Physical examinations Vital Signs, Safety Lab, assessment of adverse events, tolerability
Measured: weekly assessment of physical status, safety labs, adverse events during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Pharmakokinetics (PK)
BT061 plasma levels, AUC, time to elimination, accumulation after multiple doses, time course of related hematological parameters (e.g. WBC count)
Measured: weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiří Vencovský, MD, Study chair, Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481493
- Sponsor's protocol ID
- 979
- Other IDs
- 2010-018485-24
- Status last verified
- Feb 2015
- First submitted
- 17 Oct 2011
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061
- ClinicalTrials.gov ID
- NCT01481493
- Acronym / sponsor ID
- 979
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (MTX).
Detailed description
Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a double-blind set-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Biological: BT061BT061 monoclonal antibody (subcutaneous) |
| Placebo | Placebo comparator | Biological: Placebosubcutaneous injection of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
- Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
- Duration of RA more than 12 month
- History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
- MTX treatment at least 6 month with a stable dose at least 15mg MTX
Key exclusion criteria (4 listed)
- Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
- Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
- treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
- Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
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 |
|---|---|---|
| BT061Also: immune-modulatory antibody BT061subcutaneous administration of the monoclonal antibody BT061 | Biological | Active Treatment |
| PlaceboAlso: end formulation buffer without active ingredientsubcutaneous injection of placebo | Biological | Placebo |
Primary outcome
dose-response information
Time frame: ACR20 response at week 13 (1 week after last dose of study drug)
ACR20 response (percentage of patients reaching or exceeding at least a 20% improvement in their arthritis assessment according to the criteria of the American College of Rheumatology)
3 secondary outcomes
efficacy responses other than ACR20, including questionaires, and their dose dependencies
Time frame: weekly assessment of ACR arthritis status during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Safety and tolerability of the various dose levels and of placebo
Time frame: weekly assessment of physical status, safety labs, adverse events during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Pharmakokinetics (PK)
Time frame: weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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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.
Jiří Vencovský, MD study chair
Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BT061 in people with Rheumatoid Arthritis, run by Biotest at 39 sites in 7 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Poland, Italy, Spain, Germany, Czechia and 2 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dose-response information (time frame: ACR20 response at week 13 (1 week after last dose of study drug)). 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 20 Feb 2015.