Rheumatoid ArthritisPhase 2TELLUSNCT02393378
Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate
A Phase 2 study testing Namilumab, Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by Takeda at 13 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Namilumab, Adalimumab and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 8 Apr 2015to 16 Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is diagnosed with adult onset rheumatoid arthritis (RA) as defined by the 2010 The American College of Rheumatology (ACR)/The European League Against Rheumatism criteria for the classification of RA within 6 months prior to Screening Visit.
- Has active disease defined as:
- swollen joint count ≥4 and tender joint count ≥4 (referred to the 28 joint-count system) at Screening and Baseline Visits, and
- C-reactive protein ≥4.3 mg/L and erythrocyte sedimentation rate ≥28 mm/hr at Baseline Visits, and
- imaging (ultrasound power doppler) evidence of moderate to severe inflammation of at least 1 joint of the dominant hand metacarpophalangeal (MCP) and/or wrist) at Screening and Baseline Visits.
- Is receiving current treatment with Methotrexate (MTX) for RA.
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- Received MTX for at least 3 months prior to the Screening Visit.
- Received treatment with MTX ≥15 to 25 mg/week at a stable dose via the same route of administration and formulation for at least 8 weeks prior to the Baseline Visit, OR
- Participants on a stable dose for at least 8 weeks of MTX of ≥7.5 mg/week, if the MTX dose has been reduced for reasons of documented intolerance to MTX.
- Is willing to continue or initiate treatment with oral folic acid (at least 5 mg/week) or equivalent and be treated during the entire trial (mandatory co-medication for MTX treatment).
- Has a posterior, anterior, and lateral chest x-ray obtained within the last 3 months before Screening or at the Screening visit without any signs of clinically significant pulmonary disease.
Who cannot join
- Has received biologic disease-modifying antirheumatic drugs for the treatment of RA.
- Have a history of or currently inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, or Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome).
- Has any major systemic features of RA, for example, Felty's syndrome, vasculitis, or interstitial fibrosis of the lungs.
- Diagnosed with primary fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study or a diagnosis of any systemic inflammatory condition other than RA.
- Has a history of juvenile idiopathic arthritis or RA onset prior to age 16 years.
- Required to take excluded medications
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- Not willing to take folic/folinic acid (as part of MTX regimen, according to country-specific practices) in order to minimize toxicity.
- Has an underlying condition that predisposes to infections (e.g., immunodeficiency, poorly controlled diabetes history, splenectomy).
- Has a history of clinically significant interstitial lung disease, for example, history of chronic or recurrent pulmonary infection where macrophages are important for the clearance of the infection, for example, pneumocystis carinii pneumonia, allergic bronchopulmonary aspergillosis, nocardia infections, Actinomyces infection.
- Presence or history of active tuberculosis (TB) or latent TB infection, where no anti-TB treatment has been given or where successful completion of an appropriate course of anti-TB therapy cannot be documented.
- A positive QuantiFERON-TB Gold test and/or evidence of active or latent TB by chest x-ray at Screening Visit, not accompanied by initiation of an approved regimen of anti-TB therapy at least 12 months prior to the Baseline Visit.
- Has a known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV), or has serological findings at the Screening Visit which indicate active or latent hepatitis B, hepatitis C or HIV infection.
- Has a clinically relevant decrease in lung function at Screening, as defined by an oxygen saturation as measured by pulse oximetry (SpO2) <94% at rest.
- Has evidence of clinically significant respiratory disease on the basis of review the data from participants' respiratory assessments including chest x-ray, pulmonary function test (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]) by spirometry performed at Screening). The participants must have SpO2 ≥94%, FEV1 and/or FVC ≥60% of predicted values at Screening or at Baseline and no uncontrolled lung disease. Participant's treatment that has been modified to control lung disease within 24 weeks prior to Screening is exclusionary.
- Has a history of severe chronic obstructive pulmonary disease (COPD) and/or history of severe COPD exacerbation(s), or a history of asthma with exacerbations requiring hospitalization, within the last 12 months prior to the Screening Visit.
- Has an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2.History of MTX-associated lung toxicity.
- Has a history or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the investigator and Takeda physician, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
- Has any significant cardiac disease (eg, coronary artery disease with unstable angina, coronary heart failure New York Heart Association Class III and IV, familial long QT syndrome).
- Has a history of cancer within the last 10 years except for basal cell or squamous cell carcinomas of the skin or in situ carcinoma of the cervix treated and considered cured.
- Has a severe psychiatric or neurological disorder.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Spain4 sites
Study site
A Coruña
Study site
Fuenlabrada, Madrid
Study site
Madrid
Study site
Santiago de Compostela, La Coruna
United Kingdom3 sites
Study site
London, Greater London
Study site
Oxford, Oxfordshire
Study site
Salford, Greater Manchester
About this study
Official title: A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate
The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone.
Read the detailed description
The drug being investigated in this study is namilumab for the treatment of moderate to severe Rheumatoid Arthritis (RA). This study will evaluate the efficacy and safety of namilumab in participants diagnosed with RA within 6 months and insufficiently controlled by methotrexate (MTX) alone.
The study will enroll approximately 36 patients, who will be randomly assigned in a 2:1 ratio to the following open label treatment groups:
- Namilumab 150 mg + MTX + folic acid
- Adalimumab 40 mg + MTX + folic acid
Imaging techniques, including Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), will be used to measure changes in the dominant hand and the wrist.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is a maximum of 42 weeks, including follow-up period. Participants will make 16 visits to the site and will be followed up by telephone twice after end of treatment.
A strategic decision was made to stop the study on 18 December 2015 in order to fully understand the data from the psoriasis study (ClinicalTrials.gov Identifier:NCT02129777) and wait for the results of the formal proof of concept study (ClinicalTrials.gov Identifier: (NCT02379091) in participants with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Namilumab, Adalimumab, Methotrexate, Folic Acid
- Keywords
- Drug Therapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NamilumabDrug
Namilumab injection
AdalimumabDrug
Adalimumab SC injection
MethotrexateDrug
Methotrexate tablet
Folic AcidDrug
Folic Acid Tablet
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40 mg | Experimental | Adalimumab 40 mg, subcutaneous (SC) injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication. Receives: Drug: Adalimumab; Drug: Methotrexate; Drug: Folic Acid |
| Namilumab 150 mg | Active comparator | Namilumab 150*2 mg, SC injection at Week 0 followed by 150 mg, SC injections at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication. Receives: Drug: Namilumab; Drug: Methotrexate; Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24
A Magnetic Resonance Imaging (MRI) of Metacarpophalangeal (MCP) and Wrist of the dominant hand was performed at the baseline and at week 24. Change from the Baseline was assessed according to the Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials RA-MRI scoring (OMERACT RAMRIS) Standard. RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis is scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema is scored 0 (normal) to 69 (maximum articular bone involvement). Erosion is scored from 0 (normal) to 230 (maximum erosion of articular bone). Total RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number = increasing severity.
Measured: Baseline and Week 24
Secondary outcomes (5)
Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24
DCE-MRI was used to measure synovial vascular perfusion. The change from baseline in DCE-MRI parameters of synovial vascular perfusion at Week 24 were measured.
Measured: Baseline and Week 24
Number of Participants Who Achieved Remission at Week 24
Remission is defined as the number of participants who achieved Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) score <2.6. The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis (RA) and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Measured: Week 24
Number of Participants Who Achieved Low Disease Activity at Week 24
Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) low disease activity is defined as a score <3.2. The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Measured: Week 24
Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24
The American College of Rheumatology (ACR) 20 is composite index of improvement in RA proposed by the ACR. ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.
Measured: Week 24
Change From Baseline in DAS28-CRP Score
The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Measured: Baseline Up to Week 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start8 Apr 2015
- Primary completion27 Jun 2016
- Study completion16 Nov 2016
Why it stopped: Strategic decision - to understand data from psoriasis study - NCT02129777 and wait for results of formal proof of concept study - NCT02379091.
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393378
- Sponsor's protocol ID
- MT203-2004
- Other IDs
- U1111-1160-1791, 15/SC/0020, 2014-002945-23, REec-2015-1508, 2014
- Acronym
- TELLUS
- Status last verified
- Aug 2018
- First submitted
- 15 Mar 2015
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate
- ClinicalTrials.gov ID
- NCT02393378
- Acronym / sponsor ID
- TELLUS / MT203-2004
- Conditions
- Rheumatoid Arthritis
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision - to understand data from psoriasis study - NCT02129777 and wait for results of formal proof of concept study - NCT02379091.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone.
Detailed description
The drug being investigated in this study is namilumab for the treatment of moderate to severe Rheumatoid Arthritis (RA). This study will evaluate the efficacy and safety of namilumab in participants diagnosed with RA within 6 months and insufficiently controlled by methotrexate (MTX) alone.
The study will enroll approximately 36 patients, who will be randomly assigned in a 2:1 ratio to the following open label treatment groups:
- Namilumab 150 mg + MTX + folic acid
- Adalimumab 40 mg + MTX + folic acid
Imaging techniques, including Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), will be used to measure changes in the dominant hand and the wrist.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is a maximum of 42 weeks, including follow-up period. Participants will make 16 visits to the site and will be followed up by telephone twice after end of treatment.
A strategic decision was made to stop the study on 18 December 2015 in order to fully understand the data from the psoriasis study (ClinicalTrials.gov Identifier:NCT02129777) and wait for the results of the formal proof of concept study (ClinicalTrials.gov Identifier: (NCT02379091) in participants with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40 mg | Experimental | Drug: Adalimumab, Drug: Methotrexate, Drug: Folic AcidAdalimumab 40 mg, subcutaneous (SC) injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication. |
| Namilumab 150 mg | Active comparator | Drug: Namilumab, Drug: Methotrexate, Drug: Folic AcidNamilumab 150*2 mg, SC injection at Week 0 followed by 150 mg, SC injections at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is diagnosed with adult onset rheumatoid arthritis (RA) as defined by the 2010 The American College of Rheumatology (ACR)/The European League Against Rheumatism criteria for the classification of RA within 6 months prior to Screening Visit.
- Has active disease defined as:
- Is receiving current treatment with Methotrexate (MTX) for RA.
- Received MTX for at least 3 months prior to the Screening Visit.
- Received treatment with MTX ≥15 to 25 mg/week at a stable dose via the same route of administration and formulation for at least 8 weeks prior to the Baseline Visit, OR
Key exclusion criteria (20 listed)
- Has received biologic disease-modifying antirheumatic drugs for the treatment of RA.
- Have a history of or currently inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, or Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome).
- Has any major systemic features of RA, for example, Felty's syndrome, vasculitis, or interstitial fibrosis of the lungs.
- Diagnosed with primary fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study or a diagnosis of any systemic inflammatory condition other than RA.
- Has a history of juvenile idiopathic arthritis or RA onset prior to age 16 years.
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 |
|---|---|---|
| NamilumabNamilumab injection | Drug | Namilumab 150 mg |
| AdalimumabAdalimumab SC injection | Drug | Adalimumab 40 mg |
| MethotrexateMethotrexate tablet | Drug | Adalimumab 40 mg, Namilumab 150 mg |
| Folic AcidFolic Acid Tablet | Drug | Adalimumab 40 mg, Namilumab 150 mg |
Primary outcome
Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24
Time frame: Baseline and Week 24
A Magnetic Resonance Imaging (MRI) of Metacarpophalangeal (MCP) and Wrist of the dominant hand was performed at the baseline and at week 24. Change from the Baseline was assessed according to the Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials RA-MRI scoring (OMERACT RAMRIS) Standard. RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis is scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema is scored 0 (normal) to 69 (maximum articular bone involvement). Erosion is scored from 0 (normal) to 230 (maximum erosion of articular bone). Total RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number = increasing severity.
5 secondary outcomes
Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved Remission at Week 24
Time frame: Week 24
Number of Participants Who Achieved Low Disease Activity at Week 24
Time frame: Week 24
Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24
Time frame: Week 24
Change From Baseline in DAS28-CRP Score
Time frame: Baseline Up to Week 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- 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.
Medical Director study director
Takeda
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Namilumab, Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by Takeda at 13 sites in 5 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 11 inclusion and 20 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, United Kingdom, Czechia, Estonia, Russia. 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 5 Feb 2019). 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?
Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24 (time frame: Baseline and Week 24). 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 5 Feb 2019.