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Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MBS2320 5 mg
MBS2320 20 mg
MBS2320 40 mg
Placebo
Sponsored by
Modern Biosciences Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis (RA), MBS2320

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR criteria for ≥3 months prior to screening.

  2. Has active RA as defined by the following minimum disease activity criteria:

    • ≥6 swollen joints (based on 66 joint counts)
    • ≥6 tender joints (based on 68 joint counts)
    • hsCRP > upper limit of normal reference range (ULN)
  3. Considered to be inadequately responding to oral or parenteral MTX therapy for ≥3 months and <10 years prior to screening and to be tolerating a dose of 15 to 25 mg per week. Participants should also be on a stable dose of folic acid (or equivalent).
  4. Except for MTX, must have discontinued all oral DMARDs prior to baseline visit.
  5. If participants are taking NSAIDs or acetaminophen, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions.
  6. If participants are taking oral corticosteroids (equivalent to prednisolone ≤10 mg), or inhaled corticosteroids, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions.

This list contains only key inclusion criteria.

Exclusion Criteria:

  1. Abnormality in the 12-lead ECG, heart rate or blood pressure at screening.
  2. Any clinically significant neurological, GI, renal, hepatic, CV, psychiatric, respiratory, metabolic, endocrine, haematological, ophthalmic, or other major disorder which, in the opinion of the Investigator, would put the participant at risk by participating in the study.
  3. Any current malignancy or a history of malignancy within 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  4. Any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
  5. Active infection that is clinically significant in the Investigator's opinion, or any infection requiring hospitalisation or treatment with intravenous antimicrobials ≤60 days of screening, or any infection requiring oral antimicrobial therapy ≤2 weeks of the baseline visit.

This list contains only key exclusion criteria.

Sites / Locations

  • Site 1201 - Univerzitetski Klinicki Centar Republike Srpske
  • Site 1204 - Univerzitetski Klinicki Centar Republike Srpske
  • Site 1202 - General Hospital Gradiška
  • Site 1308 - Medical Center Medconsult Pleven OOD
  • Site 1302 - Medical Center Artmed OOD
  • Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD
  • Site 1306 - Diagnostic- Consultative Center Convex EOOD
  • Site 1307 - Medical Center Excelsior OOD - PPDS
  • Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
  • Site 1304 - Medical Center Leo Clinic EOOD, Varna
  • Site 2103 - Enroll SpA - PPDSRecruiting
  • Site 2105 - CTR EstudiosRecruiting
  • Site 2104 - Meditek LtdaRecruiting
  • Site 2106 - Biocinetic SpARecruiting
  • Site 2107 - Hospital Dr Sotero Del RioRecruiting
  • Site 2102 - Clinical Research Chile SpA - PPDSRecruiting
  • Site 2101 - Oncocentro APYSRecruiting
  • Site 1104 - CCR Ostrava s.r.o.Recruiting
  • Site 1101 - CCR CzechRecruiting
  • Site 1103 - CLINTRIAL s.r.o.Recruiting
  • Site 1102 - MEDICAL PLUS, s.r.o.Recruiting
  • Site 2401 - Clinica Medica Con Especialidad Reumatologia
  • Site 2402 - Clinica Medica Especializada en Reumatologia
  • Site 2404 - Reumacentro
  • Site 2405 - Hospital Herrera Llerandi
  • Site 2406 - Clinica Medica Especializada en Medicina Interna
  • Site 2206 - Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SCRecruiting
  • Site 2203 - Centro de Estudios de Investigacion Basica Y Clinica SCRecruiting
  • Site 2202 - Morales Vargas Centro de Investigacion SC
  • Site 2201 - Centro de Investigación en Artritis y Osteoporosis - PPDSRecruiting
  • Site 2205 - Biológicos Especializados S.A. de C.V.
  • Site 2204 - Centro de Investigación y Tratamiento Reumatológico S.C
  • Site 1006 - ClinicMed Daniluk, Nowak Spółka JawnaRecruiting
  • Site 1002 - MICS Centrum Medyczne BydgoszczRecruiting
  • Site 1009 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w BydgoszczyRecruiting
  • Site 1007 - NZOZ Lecznica MAK-MEDRecruiting
  • Site 1004 -Twoja Przychodnia NCMRecruiting
  • Site 1001 - ETYKA Osrodek Badan KlinicznychRecruiting
  • Site 1003 - Centrum Medyczne Reuma Park NZOZRecruiting
  • Site 1008 - Centrum Medyczne AMEDRecruiting
  • Site 1402 - Institute of Rheumatology Belgrade - PPDS
  • Site 1403 - Institute of Rheumatology Belgrade - PPDS
  • Site 1404 - Military Medical Academy
  • Site 1405 - Institute of Rheumatology Belgrade - PPDS
  • Site 1406 - Institute for Treatment and Rehabilitation Niska Banja
  • Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

MBS2320 5 mg

MBS2320 20 mg

MBS2320 40 mg

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants achieving a successful composite clinical response according to the criteria for American College of Rheumatology 20% response (ACR20)
Achieving clinical response according to the criteria for ACR20: ≥20% improvement in 68-Tender Joint Count; ≥20% improvement in 66-SJC; and ≥20% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)

Secondary Outcome Measures

Change in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores
Difference in mean change from baseline in each RAMRIS score (synovitis, bone oedema, and bone erosion scores measured with MRI).
Percentage of participants achieving clinical response according to the criteria for American College of Rheumatology 50% response (ACR50)
Achieving clinical response according to the criteria for ACR50: ≥50% improvement in 68-Tender Joint Count; ≥50% improvement in 66-SJC; and ≥50% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)
Percentage of participants achieving clinical response according to the criteria for American College of Rheumatology 70% response (ACR70)
Achieving clinical response according to the criteria for ACR70: ≥70% improvement in 68-Tender Joint Count; ≥70% improvement in 66-SJC; and ≥70% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)
Percentage of participants achieving DAS28-hsCRP remission
Difference in mean change from baseline in DAS28-hsCRP. DAS28-hsCRP is a composite score that includes 4 variables: tender and swollen joint counts (based on 28 joints each), participant's global assessment of disease activity, and hsCRP.
Change in cartilage loss (CARLOS) scores
Change in cartilage loss in the hand and wrist from baseline measured with MRI and scored using a validated 9-point scale with 0.5 increments where 0.0 is no cartilage loss and 4.0 is complete ankylosis.
Safety and tolerability of MBS2320
Incidence of all grade adverse events

Full Information

First Posted
July 12, 2022
Last Updated
March 8, 2023
Sponsor
Modern Biosciences Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05460832
Brief Title
Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
November 13, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modern Biosciences Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis (RA), MBS2320

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
MBS2320 5 mg
Arm Type
Experimental
Arm Title
MBS2320 20 mg
Arm Type
Experimental
Arm Title
MBS2320 40 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MBS2320 5 mg
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
MBS2320 20 mg
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
MBS2320 40 mg
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Percentage of participants achieving a successful composite clinical response according to the criteria for American College of Rheumatology 20% response (ACR20)
Description
Achieving clinical response according to the criteria for ACR20: ≥20% improvement in 68-Tender Joint Count; ≥20% improvement in 66-SJC; and ≥20% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores
Description
Difference in mean change from baseline in each RAMRIS score (synovitis, bone oedema, and bone erosion scores measured with MRI).
Time Frame
Week 12
Title
Percentage of participants achieving clinical response according to the criteria for American College of Rheumatology 50% response (ACR50)
Description
Achieving clinical response according to the criteria for ACR50: ≥50% improvement in 68-Tender Joint Count; ≥50% improvement in 66-SJC; and ≥50% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)
Time Frame
Week 12
Title
Percentage of participants achieving clinical response according to the criteria for American College of Rheumatology 70% response (ACR70)
Description
Achieving clinical response according to the criteria for ACR70: ≥70% improvement in 68-Tender Joint Count; ≥70% improvement in 66-SJC; and ≥70% improvement in at least 3 of the 5 following parameters: Physician's global assessment of disease activity Participant's global assessment of disease activity Participant's assessment of arthritis pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP)
Time Frame
Week 12
Title
Percentage of participants achieving DAS28-hsCRP remission
Description
Difference in mean change from baseline in DAS28-hsCRP. DAS28-hsCRP is a composite score that includes 4 variables: tender and swollen joint counts (based on 28 joints each), participant's global assessment of disease activity, and hsCRP.
Time Frame
Week 12
Title
Change in cartilage loss (CARLOS) scores
Description
Change in cartilage loss in the hand and wrist from baseline measured with MRI and scored using a validated 9-point scale with 0.5 increments where 0.0 is no cartilage loss and 4.0 is complete ankylosis.
Time Frame
Week 12
Title
Safety and tolerability of MBS2320
Description
Incidence of all grade adverse events
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Steady state plasma concentration of MBS2320
Description
Plasma concentration of MBS2320 will be determined for each sample collected at the specified time points
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR criteria for ≥3 months prior to screening. Has active RA as defined by the following minimum disease activity criteria: ≥6 swollen joints (based on 66 joint counts) ≥6 tender joints (based on 68 joint counts) hsCRP > upper limit of normal reference range (ULN) Considered to be inadequately responding to oral or parenteral MTX therapy for ≥3 months and <10 years prior to screening and to be tolerating a dose of 15 to 25 mg per week. Participants should also be on a stable dose of folic acid (or equivalent). Except for MTX, must have discontinued all oral DMARDs prior to baseline visit. If participants are taking NSAIDs or acetaminophen for stable medical conditions, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit and the doses of the medications should be kept stable throughout the study. If participants are taking oral corticosteroids (equivalent to prednisolone ≤10 mg), or inhaled corticosteroids, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions. This list contains only key inclusion criteria. Exclusion Criteria: Abnormality in the 12-lead ECG, heart rate or blood pressure at screening. Any clinically significant neurological, GI, renal, hepatic, CV, psychiatric, respiratory, metabolic, endocrine, haematological, ophthalmic, or other major disorder which, in the opinion of the Investigator, would put the participant at risk by participating in the study. Any current malignancy or a history of malignancy within 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Any other inflammatory or arthritic disease in addition to RA that may interfere with the study. Active infection that is clinically significant in the Investigator's opinion, or any infection requiring hospitalisation or treatment with intravenous antimicrobials ≤60 days of screening, or any infection requiring oral antimicrobial therapy ≤2 weeks of the baseline visit. Clinically significant features of arthroses that could interfer with study assessments and objectives. This list contains only key exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bouilloux
Organizational Affiliation
Modern Biosciences Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Site 1201 - Univerzitetski Klinicki Centar Republike Srpske
City
Banja Luka
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1204 - Univerzitetski Klinicki Centar Republike Srpske
City
Banja Luka
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1202 - General Hospital Gradiška
City
Gradiška
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1308 - Medical Center Medconsult Pleven OOD
City
Pleven
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1302 - Medical Center Artmed OOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1306 - Diagnostic- Consultative Center Convex EOOD
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1307 - Medical Center Excelsior OOD - PPDS
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1304 - Medical Center Leo Clinic EOOD, Varna
City
Varna
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2103 - Enroll SpA - PPDS
City
Providencia
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2105 - CTR Estudios
City
Providencia
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2104 - Meditek Ltda
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2106 - Biocinetic SpA
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2107 - Hospital Dr Sotero Del Rio
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2102 - Clinical Research Chile SpA - PPDS
City
Valdivia
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2101 - Oncocentro APYS
City
Viña del Mar
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1104 - CCR Ostrava s.r.o.
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1101 - CCR Czech
City
Pardubice
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1103 - CLINTRIAL s.r.o.
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1102 - MEDICAL PLUS, s.r.o.
City
Uherské Hradište
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2401 - Clinica Medica Con Especialidad Reumatologia
City
Guatemala
Country
Guatemala
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2402 - Clinica Medica Especializada en Reumatologia
City
Guatemala
Country
Guatemala
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2404 - Reumacentro
City
Guatemala
Country
Guatemala
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2405 - Hospital Herrera Llerandi
City
Guatemala
Country
Guatemala
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2406 - Clinica Medica Especializada en Medicina Interna
City
Guatemala
Country
Guatemala
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2206 - Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
City
Burócratas del Estado
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2203 - Centro de Estudios de Investigacion Basica Y Clinica SC
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2202 - Morales Vargas Centro de Investigacion SC
City
León
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2201 - Centro de Investigación en Artritis y Osteoporosis - PPDS
City
Mexicali
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2205 - Biológicos Especializados S.A. de C.V.
City
Mexico City
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 2204 - Centro de Investigación y Tratamiento Reumatológico S.C
City
Miguel Hidalgo
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1006 - ClinicMed Daniluk, Nowak Spółka Jawna
City
Bialystok
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1002 - MICS Centrum Medyczne Bydgoszcz
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1009 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1007 - NZOZ Lecznica MAK-MED
City
Nadarzyn
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1004 -Twoja Przychodnia NCM
City
Nowa Sól
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1001 - ETYKA Osrodek Badan Klinicznych
City
Olsztyn
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1003 - Centrum Medyczne Reuma Park NZOZ
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1008 - Centrum Medyczne AMED
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1402 - Institute of Rheumatology Belgrade - PPDS
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1403 - Institute of Rheumatology Belgrade - PPDS
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1404 - Military Medical Academy
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1405 - Institute of Rheumatology Belgrade - PPDS
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1406 - Institute for Treatment and Rehabilitation Niska Banja
City
Niška Banja
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk
Facility Name
Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad
City
Novi Sad
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hylands
Phone
+44 (0)207 444 0066
Email
ist06@istesso.co.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

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