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Tests treatment safety and results for Rheumatoid Arthritis
Official title A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
ClinicalTrials.gov ID: NCT07137598
What this study is testing
What is Afimkibart?
Afimkibart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis.
Also referred to as PF 06480605, RVT-3101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on...
- Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology...
- Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug...
You likely can't join if
- Have failed more than two TNF inhibitors or JAK inhibitors
- Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
- Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation...
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids...
See the full eligibility criteria
- Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count)
- Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
- Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
- Have failed more than two TNF inhibitors or JAK inhibitors
- Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
- Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
- History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
- History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated...
- 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
- History of organ transplant
- Any identified confirmed congenital or acquired immunodeficiency
- Abnormal laboratory values and liver function test
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- Los Angeles, California, United States
- Upland, California, United States
- Tamarac, Florida, United States
- Willowbrook, Illinois, United States
- Lake Charles, Louisiana, United States
- Columbus, Ohio, United States
- Duncansville, Pennsylvania, United States
- Houston, Texas, United States
- Tomball, Texas, United States
- Chesapeake, Virginia, United States
- Glendale, Wisconsin, United States
- Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Brussels, Belgium
- Leuven, Belgium
- Brasília, Federal District, Brazil
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; Los Angeles, California, United States; Upland, California, United States; Tamarac, Florida, United States; Willowbrook, Illinois, United States; Lake Charles, Louisiana, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.