Rheumatoid ArthritisPhase 2NCT01712399
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
A Phase 2 study testing Mavrilimumab 100 mg in people with Rheumatoid Arthritis, run by MedImmune LLC at 52 sites in 19 countries.
Trial summary
A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mavrilimumab 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 52 sitesin 19 countries
- Study dates
- 28 Jan 2013to 30 Dec 2015
- Phase
- Phase 2
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
- No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist
Who cannot join
- Subjects who have been permanently discontinued from investigational product in previous qualifying study.
- Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
Trial locations and contacts
52 sites in 19 countries.
52 sites in 19 countries
Czechia6 sites
Research Site
Bruntál
Research Site
Jihlava
Research Site
Ostrava - Trebovice
Research Site
Prague
Research Site
Uherské Hradiště
Research Site
Zlín
Poland5 sites
Research Site
Gdynia
Research Site
Grodzisk Mazowiecki
Research Site
Katowice
Research Site
Krakow
Research Site
Wroclaw
Russia5 sites
Research Site
Barnaul
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Yaroslavl
Ukraine5 sites
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Lutsk
Research Site
Vinnytsia
Argentina4 sites
Research Site
Ciudad Autonoma Buenos Aires
Research Site
Ciudad Autonoma de Buenos Aire
Research Site
Rosario
Research Site
San Miguel de Tucumán
Hungary4 sites
Research Site
Baja
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Debrecen
Israel3 sites
Research Site
Ashkelon
Research Site
Kfar Saba
Research Site
Petah Tikva
Spain3 sites
Research Site
Barcelona
Research Site
Málaga
Research Site
Santiago de Compostela
About this study
Official title: An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
Read the detailed description
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Mavrilimumab 100 mg
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mavrilimumab 100 mgBiological
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
| Study group | Role | What they receive |
|---|---|---|
| Mavrilimumab 100 mg | Experimental | Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. Receives: Biological: Mavrilimumab 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Measured: From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Measured: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Measured: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Measured: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Measured: From Week 24 to Week 130 at specified time points
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Measured: From Week 24 to Week 130 at specified time points
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Measured: From Week 24 to Week 156 at specified time points
Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.
Measured: From Week 0 to Week 132 at specified time points
Oxygen Saturation Levels by Pulse Oximetry
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Measured: From Week 0 to Week 132 at specified time points
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Measured: From Week 12 to Week 156 at specified time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study start28 Jan 2013
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Why it stopped: The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712399
- Sponsor's protocol ID
- CD-IA-CAM-3001-1109
- Other IDs
- Earth Explorer X
- Status last verified
- May 2017
- First submitted
- 19 Oct 2012
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Burmester GR, McInnes IB, Kremer JM, Miranda P, Vencovsky J, Godwood A, Albulescu M, Michaels MA, Guo X, Close D, Weinblatt M. Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor alpha Monoclonal Antibody: Long-Term Safety and Efficacy in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2018 May;70(5):679-689. doi: 10.1002/art.40420. Epub 2018 Mar 31.
PubMed 29361199
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01712399
- Acronym / sponsor ID
- CD-IA-CAM-3001-1109
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
- Enrolment
- 409 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2013
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
Detailed description
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavrilimumab 100 mg | Experimental | Biological: Mavrilimumab 100 mgParticipants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
- No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist
Key exclusion criteria (2 listed)
- Subjects who have been permanently discontinued from investigational product in previous qualifying study.
- Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
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 |
|---|---|---|
| Mavrilimumab 100 mgParticipants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years | Biological | Mavrilimumab 100 mg |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
Time frame: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Time frame: From Week 24 to Week 130 at specified time points
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Time frame: From Week 24 to Week 130 at specified time points
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Time frame: From Week 24 to Week 156 at specified time points
Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.
Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
Time frame: From Week 0 to Week 132 at specified time points
Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.
Oxygen Saturation Levels by Pulse Oximetry
Time frame: From Week 0 to Week 132 at specified time points
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: From Week 12 to Week 156 at specified time points
DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29361199Burmester GR, McInnes IB, Kremer JM, Miranda P, Vencovsky J, Godwood A, Albulescu M, Michaels MA, Guo X, Close D, Weinblatt M. Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor alpha Monoclonal Antibody: Long-Term Safety and Efficacy in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2018 May;70(5):679-689. doi: 10.1002/art.40420. Epub 2018 Mar 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mavrilimumab 100 mg in people with Rheumatoid Arthritis, run by MedImmune LLC at 52 sites in 19 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 2 inclusion and 2 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Czechia, Poland, Russia, Ukraine, Argentina and 14 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 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?
Yes. Results are posted in the registry (first posted 1 Jun 2017). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712399, which also lists 1 linked publication.
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 1 Jun 2017.