Rheumatoid ArthritisPhase 2NCT02795299
Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis
A Phase 2 study testing Gerilimzumab, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Bird Rock Bio, Inc..
Trial summary
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Gerilimzumab, Methotrexate and Folic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Sep 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet the following inclusion criteria to be enrolled in the study:
- Men or women, ages 18 to 80 years, inclusive;
- Diagnosis of moderately to severely active RA for at least 3 months prior to screening as according to 2010 EULAR/ACR classification criteria for at least 3 months prior to screening with ACR functional class I-III;
- Have active RA with ≥4 swollen and ≥4 tender joints (28 joint count) throughout the screening period (all visits) and baseline visit at Week 0 baseline. Must meet above criteria in order to enter screening phase at all screening visits to be randomized;
- Current treatment with stable dose of oral MTX (i.e., 15-25 mg/week for >6 weeks) prior to screening. Patients will remain on their current dose and route of administration of MTX through the screening period. Patients must also remain on a stable dose and route of administration of MTX and folic acid supplementation throughout the randomized treatment phase of the study. Patients on a dose of MTX <15 mg QWK may have their dose of MTX increased to 15mg QWK at the initial screening visit providing that they meet all other entry criteria;
- Demonstrated an inadequate response to previous or current MTX treatment and/or a single TNFα inhibitor;
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- C-reactive Protein (CRP) above the ULN for the central laboratory at the time of screening;
- Positive Cyclic Citrullinated Peptide (CCP) antibody or Rheumatoid Factor (RF) from the central laboratory at the screening visit;
- Previous treatment with a single TNFα antagonist is permitted, providing there has been:
- An inadequate response to an approved or investigational: TNFα antagonist despite completing an induction regimen with any approved or experimental TNFα antagonist per the current labeling, study protocol or institutional standard of care
- Recurrence of symptoms during maintenance dosing with a TNFα antagonist following prior clinical benefit(discontinuation despite clinical benefit does not qualify)
- History of intolerance to a TNFα antagonist (including but not limited to infusion or injection related reaction, demyelination, congestive heart failure or serious infection)
- Considered to be in stable health in the opinion of the Investigator, as determined by:
- A pre-study physical examination with no clinically significant abnormalities aside from those related to rheumatoid disease
- Vital signs (VS): heart rates at screening must be ≥ 50 bpm; and systolic blood pressure (SBP) and diastolic blood pressure (DBP) ≥ 90 and ≥ 55, respectively at all screening visits
- Liver function tests (ALT/AST, bilirubin and Alkaline phosphatase) <2X the upper limit of normal) at all screening visits
- Subject is not pregnant (negative pregnancy test) or nursing and is not planning pregnancy or initiation of breast-feeding over the duration of the study
- Women of child-bearing potential must use effective contraception for the duration of the study until 180 days after study treatment discontinuation
- Men who have sexual relationships with women of child-bearing potential will agree to use an effective means of contraception for the duration of the study until 60 days after study treatment discontinuation. In addition, men must agree not to donate sperm for the duration of the study until 60 days after study treatment discontinuation.
Who cannot join
- History of an autoimmune disease other than RA or with significant systemic involvement secondary to RA. Patients with a history of diabetes and or thyroiditis are eligible to participate if all other inclusion/exclusion criteria are met.
- Diagnosis of any other arthritis (e.g., psoriatic arthritis or ankylosing spondylitis)
- Secondary, non-inflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion could interfere with the evaluation of the effect of study medication on the subjects primary diagnosis of RA
- Concomitant medication/therapy exclusions:
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (except TNFα inhibitors (as described above) prior to screening;
- Any prior exposure to natalizumab, efalizumab, rituximab, tocilizumab, or abatacept, or tofacitinib or any other Janus kinase [JAK]-inhibitors, or anti IL-1 therapies;
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- Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
- Non-biologic therapies (e.g., cyclosporine, tacrolimus, thalidomide)
- Have received prior approved or Investigational therapy blocking the interleukin-6 (IL-6) pathway, at any time
- Have received any live (includes attenuated) vaccination within 60 days prior to screening (e.g., injectable influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not) or anticipate needing any such vaccines for the duration of the study until 30 days after study treatment discontinuation
- Subject has previously received any other investigational (either approved or unapproved) drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit
- History of tuberculosis (patients with previous TB treated with local standard of care and with documentation of completion of this therapy will be allowed)
- Any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)
- Positive for Hepatitis BSAg or Hepatitis C virus
- Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 4 weeks of screening with last dose of antibiotics received within 2 weeks of screening
- History of malignancy within the 5 years prior to Screening except for adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- History of diverticulitis, diverticulosis, or intestinal perforation
- History of anaphylactic reactions to biologic therapy requiring medical attention.
About this study
Official title: Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFα Antagonist
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.
Read the detailed description
The trial will include adult patients 18-80 years of age with active disease who have demonstrated an inadequate response to treatment with MTX. Eligible patients will enter a 6-week screening period receiving 15-25 mg MTX QWK (patients will remain on their current dose and route of administration of MTX through the screening period). Patients on a dose of MTX less than 15mg QWK will have their dose of MTX increased to 15mg QWK at the initial screening visit) followed by randomization in a 1:1:1:1 ratio to 1 of 3 doses of gerilimzumab (5, 10, or 20 mg loading dose followed by 2 mg, 5 mg or 10 mg of gerilimzumab Q8W) plus MTX, or placebo plus MTX for 12 weeks of treatment. Gerilimzumab and placebo will be administered as SC injections Q8W; MTX will continue to be administered as by same route of administration (tablets, SC, or IM injection) QWK.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Gerilimzumab, Methotrexate, Folic Acid, 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.
GerilimzumabDrug
Either Gerilimzumab 5 mg followed by 2 mg, or Gerilimzumab 10 mg followed by 5 mg or Gerilimzumab 20 mg followed by 10 mg are to be administered once every 8 weeks during the treatment period of the study.
MethotrexateDrug
Methotrexate (MTX) to be administered once a week every week during the treatment period.
Folic AcidDrug
Acid folic (folate) 1mg to be administered once daily during the treatment period.
PlaceboDrug
10 mM acetate, 9% (w/v) sucrose, and 0.006% (w/v) polysorbate 20 at pH 5.2 ± 0.3
| Study group | Role | What they receive |
|---|---|---|
| Gerilimzumab 5/2 mg/Methotrexate/folate | Active comparator | • 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Receives: Drug: Gerilimzumab; Drug: Methotrexate; Drug: Folic Acid |
| Gerilimzumab 10/5mg/Methotrexate/folate | Active comparator | • 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Receives: Drug: Gerilimzumab; Drug: Methotrexate; Drug: Folic Acid |
| Gerilimzumab 20/10mg/Methotrexate/folate | Active comparator | • 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Receives: Drug: Gerilimzumab; Drug: Methotrexate; Drug: Folic Acid |
| Placebo/Methotrexate/folate | Placebo comparator | • Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Receives: Drug: Methotrexate; Drug: Folic Acid; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value)
Measured: to be applied in weeks - 6, -2, -1, 0, 4, 8, 12 and 16
Secondary outcomes (1)
The proportion of patients meeting the ACR20 (American College of Rheumatology 20%) response criteria at Week 12
Measured: to be applied in weeks -6, 0, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJan 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Study not started due to Sponsor decision to not move forward with compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bird Rock Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix
- Responsible party
- Sponsor
- Investigators
- Mauro Keiserman, Principal investigator, LMK - Serviços Medicos Sociedade Simples, Porto Alegre, Rio Grande do Sul, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795299
- Sponsor's protocol ID
- BRB-008-003
- Status last verified
- Jan 2018
- First submitted
- 2 May 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pereira IA, Mota LM, Cruz BA, Brenol CV, Fronza LS, Bertolo MB, Freitas MV, Silva NA, Louzada-Junior P, Giorgi RD, Lima RA, Pinheiro Gda R; Brazilian Society of Rheumatology. 2012 Brazilian Society of Rheumatology Consensus on the management of comorbidities in patients with rheumatoid arthritis. Rev Bras Reumatol. 2012 Aug;52(4):474-95. English, Portuguese.
PubMed 22885417McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
PubMed 22150039Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014 Sep;73(9):1616-25. doi: 10.1136/annrheumdis-2013-205137. Epub 2014 Apr 3.
PubMed 24699939Mease P, Strand V, Shalamberidze L, Dimic A, Raskina T, Xu LA, Liu Y, Smith J. A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate. Ann Rheum Dis. 2012 Jul;71(7):1183-9. doi: 10.1136/annrheumdis-2011-200704. Epub 2012 Feb 10.
PubMed 22328739
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFα Antagonist
- ClinicalTrials.gov ID
- NCT02795299
- Acronym / sponsor ID
- BRB-008-003
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started due to Sponsor decision to not move forward with compound.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bird Rock Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix
- Study start
- Jan 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 10 Jun 2016 (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.
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.
Detailed description
The trial will include adult patients 18-80 years of age with active disease who have demonstrated an inadequate response to treatment with MTX. Eligible patients will enter a 6-week screening period receiving 15-25 mg MTX QWK (patients will remain on their current dose and route of administration of MTX through the screening period). Patients on a dose of MTX less than 15mg QWK will have their dose of MTX increased to 15mg QWK at the initial screening visit) followed by randomization in a 1:1:1:1 ratio to 1 of 3 doses of gerilimzumab (5, 10, or 20 mg loading dose followed by 2 mg, 5 mg or 10 mg of gerilimzumab Q8W) plus MTX, or placebo plus MTX for 12 weeks of treatment. Gerilimzumab and placebo will be administered as SC injections Q8W; MTX will continue to be administered as by same route of administration (tablets, SC, or IM injection) QWK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gerilimzumab 5/2 mg/Methotrexate/folate | Active comparator | Drug: Gerilimzumab, Drug: Methotrexate, Drug: Folic Acid• 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily |
| Gerilimzumab 10/5mg/Methotrexate/folate | Active comparator | Drug: Gerilimzumab, Drug: Methotrexate, Drug: Folic Acid• 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily |
| Gerilimzumab 20/10mg/Methotrexate/folate | Active comparator | Drug: Gerilimzumab, Drug: Methotrexate, Drug: Folic Acid• 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily |
| Placebo/Methotrexate/folate | Placebo comparator | Drug: Methotrexate, Drug: Folic Acid, Drug: Placebo• Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Men or women, ages 18 to 80 years, inclusive;
- Diagnosis of moderately to severely active RA for at least 3 months prior to screening as according to 2010 EULAR/ACR classification criteria for at least 3 months prior to screening with ACR functional class I-III;
- Have active RA with ≥4 swollen and ≥4 tender joints (28 joint count) throughout the screening period (all visits) and baseline visit at Week 0 baseline. Must meet above criteria in order to enter screening phase at all screening visits to be randomized;
- Current treatment with stable dose of oral MTX (i.e., 15-25 mg/week for >6 weeks) prior to screening. Patients will remain on their current dose and route of administration of MTX through the screening period. Patients must also remain on a stable dose and route of administration of MTX and folic acid supplementation throughout the randomized treatment phase of the study. Patients on a dose of MTX <15 mg QWK may have their dose of MTX increased to 15mg QWK at the initial screening visit providing that they meet all other entry criteria;
- Demonstrated an inadequate response to previous or current MTX treatment and/or a single TNFα inhibitor;
Key exclusion criteria (18 listed)
- History of an autoimmune disease other than RA or with significant systemic involvement secondary to RA. Patients with a history of diabetes and or thyroiditis are eligible to participate if all other inclusion/exclusion criteria are met.
- Diagnosis of any other arthritis (e.g., psoriatic arthritis or ankylosing spondylitis)
- Secondary, non-inflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion could interfere with the evaluation of the effect of study medication on the subjects primary diagnosis of RA
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (except TNFα inhibitors (as described above) prior to screening;
- Any prior exposure to natalizumab, efalizumab, rituximab, tocilizumab, or abatacept, or tofacitinib or any other Janus kinase [JAK]-inhibitors, or anti IL-1 therapies;
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 |
|---|---|---|
| GerilimzumabEither Gerilimzumab 5 mg followed by 2 mg, or Gerilimzumab 10 mg followed by 5 mg or Gerilimzumab 20 mg followed by 10 mg are to be administered once every 8 weeks during the treatment period of the study. | Drug | Gerilimzumab 10/5mg/Methotrexate/folate, Gerilimzumab 20/10mg/Methotrexate/folate, Gerilimzumab 5/2 mg/Methotrexate/folate |
| MethotrexateMethotrexate (MTX) to be administered once a week every week during the treatment period. | Drug | Gerilimzumab 10/5mg/Methotrexate/folate, Gerilimzumab 20/10mg/Methotrexate/folate, Gerilimzumab 5/2 mg/Methotrexate/folate, Placebo/Methotrexate/folate |
| Folic AcidAcid folic (folate) 1mg to be administered once daily during the treatment period. | Drug | Gerilimzumab 10/5mg/Methotrexate/folate, Gerilimzumab 20/10mg/Methotrexate/folate, Gerilimzumab 5/2 mg/Methotrexate/folate, Placebo/Methotrexate/folate |
| Placebo10 mM acetate, 9% (w/v) sucrose, and 0.006% (w/v) polysorbate 20 at pH 5.2 ± 0.3 | Drug | Placebo/Methotrexate/folate |
Primary outcome
Change from baseline in mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value)
Time frame: to be applied in weeks - 6, -2, -1, 0, 4, 8, 12 and 16
1 secondary outcome
The proportion of patients meeting the ACR20 (American College of Rheumatology 20%) response criteria at Week 12
Time frame: to be applied in weeks -6, 0, 4, 8, 12 and 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Results publication: PubMed 22885417Pereira IA, Mota LM, Cruz BA, Brenol CV, Fronza LS, Bertolo MB, Freitas MV, Silva NA, Louzada-Junior P, Giorgi RD, Lima RA, Pinheiro Gda R; Brazilian Society of Rheumatology. 2012 Brazilian Society of Rheumatology Consensus on the management of comorbidities in patients with rheumatoid arthritis. Rev Bras Reumatol. 2012 Aug;52(4):474-95. English, Portuguese.
- Results publication: PubMed 22150039McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
- Results publication: PubMed 24699939Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014 Sep;73(9):1616-25. doi: 10.1136/annrheumdis-2013-205137. Epub 2014 Apr 3.
- Results publication: PubMed 22328739Mease P, Strand V, Shalamberidze L, Dimic A, Raskina T, Xu LA, Liu Y, Smith J. A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate. Ann Rheum Dis. 2012 Jul;71(7):1183-9. doi: 10.1136/annrheumdis-2011-200704. Epub 2012 Feb 10.
- Common Terminology Criteria for Adverse Events v4.03 (CTCAE). Publish Date: June 14, 2010. Accessed October 2010Link provided by the sponsor.
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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.
Mauro Keiserman principal investigator
LMK - Serviços Medicos Sociedade Simples, Porto Alegre, Rio Grande do Sul, Brazil
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gerilimzumab, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Bird Rock Bio, Inc..
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 19 inclusion and 18 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: withdrawn, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value) (time frame: to be applied in weeks - 6, -2, -1, 0, 4, 8, 12 and 16). 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 NCT02795299, which also lists 4 linked publications.
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 11 Jul 2018.