Rheumatoid ArthritisPhase 2NCT06565273
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
A Phase 2 study testing FBL-MTX in people with Rheumatoid Arthritis, run by SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd at 8 sites in Portugal.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients. Participants will be screened within 28 days prior to treatment period, to confirm that they meet the selection criteria for the study. 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?
- FBL-MTX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesPortugal
- Study dates
- 24 Jul 2024to 20 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects with moderate-to-severe active RA, age ≥ 18 years, Body Mass Index > 35 kg/m2.
- Diagnosis of RA according to the 2010 classification criteria of the American College of Rheumatology/ European Alliance of Associations for Rheumatology, formerly known as European League Against Rheumatism, (ACR/EULAR), with a Total Score ≥ 6/10.
- At least moderately active disease, as defined by DAS28-CRP >3.2 at Screening and Baseline, including:
- Tender joint count (TJC) ≥ 4
- Swollen joint count (SJC) ≥ 4
- C Reactive protein (CRP) ≥ 5 mg/L
Show all 12Show fewer
- Documented history of positive RA factor and/or cyclic citrullinated peptide antibody test.
- Chest X-ray performed in the previous 3 months not suggestive of tuberculosis.
- If under nonsteroidal anti-inflammatory drugs (NSAIDs), must be able to be on a stable regimen from at least 2 weeks before baseline up to end-of-study.
- If under an oral corticosteroid (≤ 10 mg per day of prednisone or equivalent), must be able to be on a stable regimen from at least 4 weeks before baseline up to EoS.
- Eligible to start treatment with an immunomodulator.
- No evidence of clinically significant active infection.
Who cannot join
- Positive Interferon-Gamma Release Assay (IGRA) test result.
- Creatinine clearance < 60 mL/min.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Portugal8 sites
Unidade Local de Saúde da Região de Aveiro, EPE
Aveiro, 3814-501
Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)
Braga, 4710-243
Unidade Local de Saúde da Guarda, EPE
Guarda, 6300-858
Unidade Local de Saúde do Alto Ave, EPE
Guimarães, 4835-044
Unidade Local de Saúde da Região de Leiria, EPE
Leiria, 2410-197
Unidade Local de Saúde do Alto Minho, EPE
Ponte de Lima, 4990-041
Unidade Local de Saúde de São João, EPE
Porto, 4200-319
Unidade Local de Saúde de Gaia e Espinho, EPE
Vila Nova de Gaia, 4434-502
About this study
Official title: Phase IIa Proof-of-Concept Study, With Dose-Titration Based on Treat-to-Target Strategy, to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Injection of Folate-based Liposomes Encapsulating Methotrexate (FBL-MTX) in Disease-modifying Antirheumatic Drugs (DMARD)-naïve Patients With Moderate-to-Severe Active Rheumatoid Arthritis and in Patients With an Inadequate Response or Intolerance to Oral MTX.
The goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients.
Participants will be screened within 28 days prior to treatment period, to confirm that they meet the selection criteria for the study.
Read more
Treatment period: The treatment period will consist of eight sequential study visits, separated by a 2-week interval.
- DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks.
- Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks.
Read the detailed description
The Sponsor is developing folate-based liposomes encapsulating methotrexate (FBL-MTX) as a putative therapy for RA, by intravenous (IV) or subcutaneous (SC) administration.
Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration, the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy.
This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA, and collection data on its safety and tolerability.
- Conditions
- Rheumatoid Arthritis
- Being tested
- FBL-MTX
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBL-MTXDrug
Patients will be administered an initial dose of FBL-MTX by subcutaneous route. Subsequent doses will be titrated according to clinical response. Maximum dosage will be 2.5 mg, every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FBL-MTX | Experimental | * DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks.
* Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks. Receives: Drug: FBL-MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Disease Activity Score (DAS) for 28-joint count using C-reactive protein (DAS28-CRP) at Week 14
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Measured: From screening up to week 14.
Change from baseline in DAS28-CRP at Weeks 4, 8, and 12.
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Measured: From screening up to weeks 4, 8 and 12.
Number of subjects who achieve remission (DAS28-CRP <2.6) at Weeks 4, 8, 12, and 14.
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Measured: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve low disease activity (DAS28-CRP <3.2) at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve American College of Rheumatology (ACR) 20% (ACR20) response at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve ACR50 response at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve ACR70 response at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Weeks 4, 8, 12, and 14.
Measured: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Week 14.
Measured: From screening up to Week 14.
Secondary outcomes (1)
Incidence of TEAEs and SAEs. Clinically relevant abnormalities in vital signs, 12-lead ECG, and laboratory parameters will be reported as AEs.
Measured: From date of screening until the date of the last post-study follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start24 Jul 2024
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Costa, MD, Principal investigator, Unidade Local de Saúde do Alto Minho, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565273
- Sponsor's protocol ID
- FBL-MTX-201
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Proof-of-Concept Study, With Dose-Titration Based on Treat-to-Target Strategy, to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Injection of Folate-based Liposomes Encapsulating Methotrexate (FBL-MTX) in Disease-modifying Antirheumatic Drugs (DMARD)-naïve Patients With Moderate-to-Severe Active Rheumatoid Arthritis and in Patients With an Inadequate Response or Intolerance to Oral MTX.
- ClinicalTrials.gov ID
- NCT06565273
- Acronym / sponsor ID
- FBL-MTX-201
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions LtdUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 21 Aug 2024 (actual)
- 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 goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients.
Participants will be screened within 28 days prior to treatment period, to confirm that they meet the selection criteria for the study.
Treatment period: The treatment period will consist of eight sequential study visits, separated by a 2-week interval.
- DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks.
- Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks.
Detailed description
The Sponsor is developing folate-based liposomes encapsulating methotrexate (FBL-MTX) as a putative therapy for RA, by intravenous (IV) or subcutaneous (SC) administration.
Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration, the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy.
This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA, and collection data on its safety and tolerability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FBL-MTX | Experimental | Drug: FBL-MTX* DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks. * Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or non-pregnant female subjects with moderate-to-severe active RA, age ≥ 18 years, Body Mass Index > 35 kg/m2.
- Diagnosis of RA according to the 2010 classification criteria of the American College of Rheumatology/ European Alliance of Associations for Rheumatology, formerly known as European League Against Rheumatism, (ACR/EULAR), with a Total Score ≥ 6/10.
- At least moderately active disease, as defined by DAS28-CRP >3.2 at Screening and Baseline, including:
- Tender joint count (TJC) ≥ 4
- Swollen joint count (SJC) ≥ 4
Key exclusion criteria (2 listed)
- Positive Interferon-Gamma Release Assay (IGRA) test result.
- Creatinine clearance < 60 mL/min.
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 |
|---|---|---|
| FBL-MTXPatients will be administered an initial dose of FBL-MTX by subcutaneous route. Subsequent doses will be titrated according to clinical response. Maximum dosage will be 2.5 mg, every 2 weeks. | Drug | FBL-MTX |
Primary outcome
Change from baseline in Disease Activity Score (DAS) for 28-joint count using C-reactive protein (DAS28-CRP) at Week 14
Time frame: From screening up to week 14.
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Change from baseline in DAS28-CRP at Weeks 4, 8, and 12.
Time frame: From screening up to weeks 4, 8 and 12.
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Number of subjects who achieve remission (DAS28-CRP <2.6) at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56*sqrt(28*Tender Joint Count) + 0.28*sqrt(28*Swollen joint count) + 0.36*ln(C-Reactive protein+1) + 0.014* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome.
Number of subjects who achieve low disease activity (DAS28-CRP <3.2) at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve American College of Rheumatology (ACR) 20% (ACR20) response at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve ACR50 response at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Number of subjects who achieve ACR70 response at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Weeks 4, 8, 12, and 14.
Time frame: From screening up to weeks 4, 8, 12 and 14.
Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Week 14.
Time frame: From screening up to Week 14.
1 secondary outcome
Incidence of TEAEs and SAEs. Clinically relevant abnormalities in vital signs, 12-lead ECG, and laboratory parameters will be reported as AEs.
Time frame: From date of screening until the date of the last post-study follow-up visit.
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 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
José Costa, MD principal investigator
Unidade Local de Saúde do Alto Minho, EPE
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FBL-MTX in people with Rheumatoid Arthritis, run by SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd at 8 sites in Portugal.
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 12 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: finished, as of the sponsor's last update on 25 Sep 2026. 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 Portugal. 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?
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?
Change from baseline in Disease Activity Score (DAS) for 28-joint count using C-reactive protein (DAS28-CRP) at Week 14 (time frame: From screening up to week 14.). The study lists 11 primary outcomes in all. 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 25 Sep 2026.