Rheumatoid ArthritisPhase 2NCT02270632
A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX
A Phase 2 study testing F8IL10 and MTX in people with Rheumatoid Arthritis, run by Philogen S.p.A. at 8 sites in 3 countries.
Trial summary
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- F8IL10 and MTX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 1 Oct 2014to 8 Jun 2023
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of enrolment, patients must fulfil all of the following criteria:
- Patients aged ≥18 and < 75 years.
- Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
- Active RA (DAS28 ≥ 3.2) for ≥ 3 months at time of signing informed consent despite MTX therapy (stable regimen of methotrexate 10-25 mg/week orally, subcutaneous or intramuscular injections: stable dosage from ≥ 8 weeks before screening).
- ≥ 6 tender joints out of 68, ≥ 6 swollen joints out of 66 and serum CRP > 0.5 mg/dl at screening.
- History of inadequate clinical response to at least one anti-TNF drug (applied for at least 3 months).
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- Stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥ 2 weeks prior to screening.
- All acute toxic effects of any prior therapy must have returned to classification "mild" according to CTCAE v.4.03 (published on June 14, 2010).
- Sufficient hematologic, liver and renal function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥100 x109/L, haemoglobin (Hb) ≥ 10.0 g/dL.
- Alkaline phosphatase (AP), alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) ≤ 3 x upper limit of normal range (ULN), and total bilirubin ≤ 2.0 mg/dl (34.2 µmol/L).
- Creatinine ≤ 1.5 ULN or 24 h creatinine clearance ≥ 50 mL/min.
- Documented negative test for HIV, HBV and HCV. For patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV DNA is required.
- All female subjects must have negative pregnancy test results at the screening. Women of childbearing potential must be using simultaneously double-barrier or two acceptable methods of contraception (i.e. intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the screening to three months following the last study drug administration. Pregnancy test will be repeated at the end of treatment visit.
- Male patients must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
- Signed and dated Ethics Committee-approved informed consent form indicating that the patient has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Chest X rays performed (for other reasons than the present clinical trial) within a period of 3 months prior to the screening visit. However, in the case the patient performs the Quantiferon TB test during the screening visit, this period can be extended to 6 months.
Who cannot join
- Patients must not be enrolled into the study if, at the time of enrolment, they have any of the following:
- Presence of active infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
- Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
- Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
- Last treatment with monoclonal antibodies (i.e., adalimumab, infliximab, golimumab, tocilizumab, certolizumab pegol) less than 8 weeks prior to first administration of study drugs. Last treatment with rituximab less than 16 weeks prior to first administration of study drugs. Last treatment with fusion proteins (i.e., abatacept, etanercept) less than 4 weeks prior to first administration of study drugs.
- Treatment with any immunosuppressant drug other than MTX and corticosteroids.
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- Active or latent tuberculosis (TB).
- HIV infection.
- Acute or chronic HBV or HCV infection, as assessed by serology or serum HBV DNA.
- History or currently active primary or secondary immunodeficiency.
- Concurrent malignancy or history of malignancy from which the patient has been disease-free for less than 5 years.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Treatment with warfarin or other coumarin derivatives.
- Heart insufficiency (> Grade II, NYHA criteria).
- Irreversible cardiac arrhythmias requiring permanent medication.
- Clinically significant (to clinical investigator's discretion) abnormalities in baseline ECG analysis.
- Uncontrolled hypertension.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy.
- Major trauma including surgery within 4 weeks prior to administration of study treatment.
- Known history of allergy or other intolerance to IL10, methotrexate, folic acid or other drugs based on human proteins/peptides/antibodies.
- Treatment with any investigational agent within the 6 weeks before study treatment.
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline or plan to receive vaccines during the study.
- Treatment with growth factors or immunomodulatory agents, including Anakinra, within 7 days of the administration of study drugs.
- Chronic pain disorders (not RA-related) that might interfere with pain evaluation.
- Patients requiring stable doses of corticosteroids > 10 mg/day (prednisone equivalent). Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
- Concurrent intra-articular corticosteroids treatment or patient who have received it within 2 weeks prior to randomization.
- History of alcohol, drug or chemical substance abuse within the 6 months prior to screening.
- Any condition that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany3 sites
Universitatsklinikum Essen
Essen
Universitatsklinikum Freiburg
Freiburg im Breisgau
Schön Klinik Hamburg Eilbek
Hamburg
Italy3 sites
Ospedale Luigi Sacco, Milano
Milan
Azienda Ospedaliera Universitaria Senese
Siena
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Switzerland2 sites
HFR Fribourg - Hôpital Cantonal
Fribourg
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
Read the detailed description
The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX.
Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms:
- Arm 1: placebo + MTX
- Arm 2: F8IL10 30 µg/kg + MTX
- Arm 3: F8IL10 160 µg/kg + MTX
F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.
- Conditions
- Rheumatoid Arthritis
- Being tested
- F8IL10, MTX, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F8IL10Drug
Also called Dekavil
F8IL10 will be administered once a week for 8 weeks (or until withdrawn from the study).
MTXDrug
Also called Methotrexate
All patients enrolled in the study will receive as concomitant therapy MTX at stable dose (10-25 mg/week), and the corresponding fixed dose of folic acid.
PlaceboDrug
Placebo will be administered once a week for 8 weeks (or until withdrawn from the study).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo Receives: Drug: MTX; Drug: Placebo |
| Arm 2 | Experimental | F8IL10, 30 μg/kg Receives: Drug: F8IL10; Drug: MTX |
| Arm 3 | Experimental | F8IL10, 160 μg/kg Receives: Drug: F8IL10; Drug: MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DAS28-CRPscore
Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms.
Measured: At week 9
Secondary outcomes (15)
Number of Participants with Adverse Events
Safety and tolerability of subcutaneous F8IL10 when administered in combination with MTX.
Measured: Up to 8 months from randomization
Response rate according to ACR and EULAR criteria
Proportion of patients achieving an ACR clinical response (ACR20, 50 and 70) and time to onset of these criteria.
Measured: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Clinical Remission and low-disease activity (DAS28-CRP)
Proportion of patients achieving clinical remission and clinical low- disease activity according to DAS 28-CRP (DAS28 < 2.6 and 2.6≤ DAS28 <3.2, respectively) and time to onset of these criteria.
Measured: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Clinical Remission and low-disease activity (SDAI score)
Proportion of patients achieving clinical remission and clinical low-disease activity according to SDAI score (SDAI ≤ 3.3 and SDAI ≤ 11.0) and time to onset of these criteria
Measured: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute count and change from baseline in tender and swollen joint counts
The tender joint count represents the number of joints in which pain is reported at rest with pressure or on movement.
The swollen joint count represents the number of joints in which there is synovial fluid and/or soft tissue swelling.
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute score and change from baseline in physician's and patient's global assessments of disease activity (100 mm VAS)
Patient's and Physician's global assessment of disease activity.
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute score and change from baseline in patient assessment of the pain intensity at each visit (100 mm VAS)
Patient's assessment of pain.
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Proportion of patients that experienced significant change from baseline in functional status (HAQ-DI)
Measured: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Proportion of patients that experienced significant change from baseline in functional status (SF-36)
Measured: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
HAQ score and change from baseline in HAQ score
Measured: 1) week 1; 2) week 9; 3) from week 12 up to week 32, every 4 weeks
Inflammatory parameters CRP or ESR and change from baseline
Laboratory assessments (CRP, ESR)
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Human anti-fusion protein antibodies (HAFA) levels
Investigate the potential induction of human anti-fusion protein antibodies (HAFA) through standard laboratory analysis.
Measured: 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks
Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Clinically Meaningful Changes in Vital Signs and Physical Examinations
Measured: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Changes in absolute counts and relative percentages of main biomarker/cytokines
Biomarkers :IgA, IgE, Soluble IL-2 receptor, Soluble IL-1 receptor antagonist, MMP3); cytokines: IL-1α, IL-1β, TNFα, IL2, IL6, IL17, IL18, IL22, VEGF
Measured: 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start1 Oct 2014
- Primary completionApr 2019
- Study completion8 Jun 2023
Why it stopped: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.
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.
- More trials run by Philogen S.p.A.The 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270632
- Sponsor's protocol ID
- PH-F8IL10-03/13
- Status last verified
- Jun 2023
- First submitted
- 16 Oct 2014
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.
- ClinicalTrials.gov ID
- NCT02270632
- Acronym / sponsor ID
- PH-F8IL10-03/13
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 21 Oct 2014 (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.
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
Detailed description
The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX.
Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms:
- Arm 1: placebo + MTX
- Arm 2: F8IL10 30 µg/kg + MTX
- Arm 3: F8IL10 160 µg/kg + MTX
F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: MTX, Drug: PlaceboPlacebo |
| Arm 2 | Experimental | Drug: F8IL10, Drug: MTXF8IL10, 30 μg/kg |
| Arm 3 | Experimental | Drug: F8IL10, Drug: MTXF8IL10, 160 μg/kg |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients aged ≥18 and < 75 years.
- Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
- Active RA (DAS28 ≥ 3.2) for ≥ 3 months at time of signing informed consent despite MTX therapy (stable regimen of methotrexate 10-25 mg/week orally, subcutaneous or intramuscular injections: stable dosage from ≥ 8 weeks before screening).
- ≥ 6 tender joints out of 68, ≥ 6 swollen joints out of 66 and serum CRP > 0.5 mg/dl at screening.
- History of inadequate clinical response to at least one anti-TNF drug (applied for at least 3 months).
Key exclusion criteria (29 listed)
- Patients must not be enrolled into the study if, at the time of enrolment, they have any of the following:
- Presence of active infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
- Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
- Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
- Last treatment with monoclonal antibodies (i.e., adalimumab, infliximab, golimumab, tocilizumab, certolizumab pegol) less than 8 weeks prior to first administration of study drugs. Last treatment with rituximab less than 16 weeks prior to first administration of study drugs. Last treatment with fusion proteins (i.e., abatacept, etanercept) less than 4 weeks prior to first administration of study drugs.
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 |
|---|---|---|
| F8IL10Also: DekavilF8IL10 will be administered once a week for 8 weeks (or until withdrawn from the study). | Drug | Arm 2, Arm 3 |
| MTXAlso: MethotrexateAll patients enrolled in the study will receive as concomitant therapy MTX at stable dose (10-25 mg/week), and the corresponding fixed dose of folic acid. | Drug | Arm 1, Arm 2, Arm 3 |
| PlaceboPlacebo will be administered once a week for 8 weeks (or until withdrawn from the study). | Drug | Arm 1 |
Primary outcome
Change from baseline in DAS28-CRPscore
Time frame: At week 9
Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms.
15 secondary outcomes
Number of Participants with Adverse Events
Time frame: Up to 8 months from randomization
Response rate according to ACR and EULAR criteria
Time frame: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Clinical Remission and low-disease activity (DAS28-CRP)
Time frame: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Clinical Remission and low-disease activity (SDAI score)
Time frame: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute count and change from baseline in tender and swollen joint counts
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute score and change from baseline in physician's and patient's global assessments of disease activity (100 mm VAS)
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Absolute score and change from baseline in patient assessment of the pain intensity at each visit (100 mm VAS)
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Proportion of patients that experienced significant change from baseline in functional status (HAQ-DI)
Time frame: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
Proportion of patients that experienced significant change from baseline in functional status (SF-36)
Time frame: 1) week 9; 2) from week 12 up to week 32, every 4 weeks
HAQ score and change from baseline in HAQ score
Time frame: 1) week 1; 2) week 9; 3) from week 12 up to week 32, every 4 weeks
Inflammatory parameters CRP or ESR and change from baseline
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Human anti-fusion protein antibodies (HAFA) levels
Time frame: 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks
Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Clinically Meaningful Changes in Vital Signs and Physical Examinations
Time frame: 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks
Changes in absolute counts and relative percentages of main biomarker/cytokines
Time frame: 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks
Results and safety
The study was stopped early (reason given: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F8IL10 and MTX in people with Rheumatoid Arthritis, run by Philogen S.p.A. at 8 sites in 3 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 18 inclusion and 29 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Italy, Switzerland. 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 was stopped early (reason given: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.). Results are not available in the source record.
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 DAS28-CRPscore (time frame: At week 9). 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 12 Jun 2023.