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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03001219
• Date of registration: 20/12/2016
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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
• Scientific 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
• Date of first enrolment: December 22, 2016
• Target sample size: 109
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03001219
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Austria, Colombia, Czech Republic, Czechia, Germany, Guatemala, Italy, Mexico, Peru, Poland, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo

Drug: Methotrexate

Drug: RO7123520

Drug: Anti-TNF-alpha

Primary Outcome(s)

Percentage of Participants With Adverse Events [Time Frame: Baseline to last participant last visit (approximately 2 years)]

Percentage of Participants With Anti-Drug Antibodies [Time Frame: Baseline]

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)]

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)]

Secondary Outcome(s)

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)]

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)]

Synovial Fluid RO7123520 Concentration [Time Frame: Pre-dose (0 hour) on Days 1, 84]

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 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)]

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]

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)]

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)]

Secondary ID(s)

2016-002126-36

BP39261

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03001219