Rheumatoid ArthritisPhase 2NCT03001219
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
A Phase 2 study testing Anti-TNF-alpha, Methotrexate and RO7123520 in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 81 sites in 11 countries.
Trial summary
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). 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?
- Anti-TNF-alpha, Methotrexate and RO7123520
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 81 sitesin 11 countries
- Study dates
- 22 Dec 2016to 6 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
- Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
- For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging
- Participants must be taking stable dose of anti-TNF-alpha therapies
- Participants on stable oral glucocorticoids within 6 weeks of planned randomization
- Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)
Who cannot join
- Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
- Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
- Active inflammatory diseases of the joints not related to RA
- Systemic autoimmune disease other than RA
- Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
- Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
Show all 13Show fewer
- RA participants functional status class IV according to the ACR 1991 criteria
- Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
- History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
- Any identified confirmed congenital or acquired immunodeficiency
- Abnormal laboratory values and liver function test
- Myocardial infarction within less than 6 months prior to participation in the study
- Severe central or peripheral nervous system diseases
Trial locations and contacts
81 sites in 11 countries.
81 sites in 11 countries
United States32 sites
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Pinnacle Research Group; Llc, Central
Anniston, Alabama, 36207
Saint Lawrence Health System; Rheumatology
Canton, New York, 13617
Low Country Rheumatology, PA
Charleston, South Carolina, 29406
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina, 29204
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, 78404
Medvin Clinical Research
Covina, California, 91723
Metroplex Clinical Research
Dallas, Texas, 75231
Omega Research Consultants LLC
DeBary, Florida, 32713-1817
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis & Osteoporosis Associates
Freehold, New Jersey
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306
San Marcus Research Clinic, Inc.
Hialeah, Florida, 33015-5110
Pioneer Research Solutions
Houston, Texas, 077099
Accurate Clinical Research
Houston, Texas, 77058-3675
Accurate Clinical Research
Houston, Texas, 77089
West Tennessee Research Institute
Jackson, Tennessee, 38305
University of California San Diego
La Jolla, California, 92093
Advanced Medical Research, LLC
Lakewood, California, 90712
Arizona Arthritis and Rheuma
Mesa, Arizona, 85202
Southwest Rheumatology
Mesquite, Texas, 75150
Paramount Medical Research
Middleburg Heights, Ohio, 44130
Millenium Research
Ormond Beach, Florida, 32174
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85037
Shores Rheumatology PC
Saint Clair Shores, Michigan, 48080
Accurate Clinical Research, Inc
Stafford, Texas, 77477
Stanford hospital & Clinics; Investigational Drug Services
Stanford, California, 94304
Atlantic Coast Rheumatology
Toms River, New Jersey, 08755
Ocean Rheumatology
Toms River, New Jersey, 08775
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania, 15090
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
Mexico10 sites
Investigacion y Biomedicina de Chihuahua, Sociedad Civil
Chichuahua, Chihuahua, 31000
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
Guadalajara, Jalisco, 44160
Javier Orozco Private Practice
Guadalajara, 44650
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)
Mérida, Yucatán, 97070
Centro Médico de las Américas
Mérida, Yucatán
Centro de Investigación; Artritis y Osteoporosis S.C.
Mexicali, 21200
Hospital Angeles Lindavista
México, 07760
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 64460
Policlinica Medica de Queretaro S.C.
Querétaro, 76000
Centro de Investigacion del Noroeste SC
Tijuana, Estado de Baja California, 22010
United Kingdom9 sites
New Queen Elizabeth Hospital Birmingham
Birmingham, B15 2WB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Glasgow Royal Infirmary
Glasgow, G4 0SF
Barts Hospital; Department of Rheumatology
London, E1 4DG
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
Newcastle U. Medical School; Institute of Cellular Medicine
Newcastle
University of Oxford, Botnar Research Centre
Oxford
Derriford Hospital
Plymouth, PL6 8DH
Lister Hospital; Rheumatology Dept
Stevenage, SG1 4AB
Spain8 sites
Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología
A Coruña, LA Coruña, 15006
Hospital de Basurto; Servicio de Reumatologia
Bilbao, Vizcaya, 48013
Hospital Universitario de la Princesa; Servicio de Reumatologia
Madrid, 28006
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria
Málaga, 29010
Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo
Murcia, 30003
Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
Santander, Cantabria, 39008
Colombia6 sites
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, 00000
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, 110221
Riesgo de Fractura S.A.
Bogotá, 110221
Fundación Instituto de Reumatología Fernando Chalem
Bogotá, 111211
Servimed S.A.S.
Bucaramanga, 680003
Healthy Medical Center SAS
Zipaquirá
Argentina4 sites
Centro de Investigaciones Reumatologicas y Osteologicas
Buenos Aires, 1111
Organización medica de Investi
Cap Fed, 1015
Cer San Juan
San Juan, 5400
Centro Medico Privado de Reumatologia; Reumathology
San Miguel, T4000AXL
Italy4 sites
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive
Bologna, Emilia-Romagna, 40138
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123
Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia
Florence, Tuscany, 50134
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
Torino, Abruzzo, 10126
Peru4 sites
Hogar Clínica San Juan de Dios
Arequipa
Clinica Internacional Sede Lima
Lima, Lima 01
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41
Instituto de Ginecología y Reproducción
Lima
Guatemala2 sites
Centro de Estudio y Tratamiento de Enfermedades Reumaticas
Guatemala City
Clinica Privada de Reumatologia Dr. Henry Briones Alvarado
Guatemala City
Austria1 site
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Anti-TNF-alpha, Methotrexate, Placebo, RO7123520
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF-alphaDrug
Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.
MethotrexateDrug
Participants will continue their pre-trial methotrexate therapy at a stable dose.
PlaceboDrug
Participants will receive intravenous infusion of placebo.
RO7123520Drug
Participants will receive intravenous infusion of RO7123520.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: Placebo |
| Part 1: RO7123520 | Experimental | Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: RO7123520 |
| Part 2: Placebo | Placebo comparator | Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: Placebo |
| Part 2: RO7123520 | Experimental | Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: RO7123520 |
| Part 3: Placebo | Placebo comparator | Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
NOTE: Part 3 was not conducted. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: Placebo |
| Part 3: RO7123520 | Experimental | Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
NOTE: Part 3 was not conducted. Receives: Drug: Anti-TNF-alpha; Drug: Methotrexate; Drug: RO7123520 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Baseline to last participant last visit (approximately 2 years)
Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Measured: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants With Anti-Drug Antibodies
Measured: Baseline
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans
Measured: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Secondary outcomes (10)
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity.
Measured: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Measured: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving DAS28 Remission at Week 12
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Measured: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving CDAI Remission at Week 12
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity. CDAI remission is defined as a score of less than or equal to 2.8.
Measured: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving ACR20 Response at Week 12
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Measured: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving ACR70 Response at Week 12
The ACR70 is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Measured: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
The SDAI consists of 5 parameters used to assess RA disease activity: 28-joint count assessments of tenderness and swelling, participant and investigator global assessments, and CRP levels. A composite score is produced, with remission defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26.
Measured: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
The HAQ-DI is a 20-item, validated questionnaire used to assess difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 "without any difficulty" to 3 "unable to do." A lower HAQ-DI score indicates better quality of life. Subscale scores are combined and the mean value is reported for each arm per timepoint.
Measured: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Serum RO7123520 Concentration
Measured: Pre-dose (0 hour), 1 hour post infusion (duration of infusion: approximately 1 hour) on Days 1, 14, 28, 56; Pre-dose (0 hour) on Days 84, 112
Synovial Fluid RO7123520 Concentration
Measured: Pre-dose (0 hour) on Days 1, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start22 Dec 2016
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Why it stopped: The trial was prematurely terminated due to a lack of efficacy of the investigational drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001219
- Sponsor's protocol ID
- BP39261
- Other IDs
- 2016-002126-36, 2016
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2016
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors
- ClinicalTrials.gov ID
- NCT03001219
- Acronym / sponsor ID
- BP39261
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was prematurely terminated due to a lack of efficacy of the investigational drug.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: PlaceboParticipants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. |
| Part 1: RO7123520 | Experimental | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: RO7123520Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. |
| Part 2: Placebo | Placebo comparator | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: PlaceboParticipants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. |
| Part 2: RO7123520 | Experimental | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: RO7123520Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. |
| Part 3: Placebo | Placebo comparator | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: PlaceboParticipants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted. |
| Part 3: RO7123520 | Experimental | Drug: Anti-TNF-alpha, Drug: Methotrexate, Drug: RO7123520Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
- Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
- For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging
- Participants must be taking stable dose of anti-TNF-alpha therapies
- Participants on stable oral glucocorticoids within 6 weeks of planned randomization
Key exclusion criteria (13 listed)
- Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
- Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
- Active inflammatory diseases of the joints not related to RA
- Systemic autoimmune disease other than RA
- Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
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 |
|---|---|---|
| Anti-TNF-alphaParticipants will continue their pre-trial anti-TNF-alpha therapy at a stable dose. | Drug | Part 1: Placebo, Part 1: RO7123520, Part 2: Placebo, Part 2: RO7123520, Part 3: Placebo, Part 3: RO7123520 |
| MethotrexateParticipants will continue their pre-trial methotrexate therapy at a stable dose. | Drug | Part 1: Placebo, Part 1: RO7123520, Part 2: Placebo, Part 2: RO7123520, Part 3: Placebo, Part 3: RO7123520 |
| PlaceboParticipants will receive intravenous infusion of placebo. | Drug | Part 1: Placebo, Part 2: Placebo, Part 3: Placebo |
| RO7123520Participants will receive intravenous infusion of RO7123520. | Drug | Part 1: RO7123520, Part 2: RO7123520, Part 3: RO7123520 |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: Baseline to last participant last visit (approximately 2 years)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12
Time frame: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Percentage of Participants With Anti-Drug Antibodies
Time frame: Baseline
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans
Time frame: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
10 secondary outcomes
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
Time frame: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
Time frame: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving DAS28 Remission at Week 12
Time frame: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving CDAI Remission at Week 12
Time frame: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving ACR20 Response at Week 12
Time frame: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Percentage of Participants Achieving ACR70 Response at Week 12
Time frame: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
Time frame: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Time frame: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Serum RO7123520 Concentration
Time frame: Pre-dose (0 hour), 1 hour post infusion (duration of infusion: approximately 1 hour) on Days 1, 14, 28, 56; Pre-dose (0 hour) on Days 84, 112
Synovial Fluid RO7123520 Concentration
Time frame: Pre-dose (0 hour) on Days 1, 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
81 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-TNF-alpha, Methotrexate and RO7123520 in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 81 sites in 11 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 6 inclusion and 13 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Mexico, United Kingdom, Spain, Colombia and 6 more countries. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: Baseline to last participant last visit (approximately 2 years)). The study lists 4 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 29 Jan 2020.