Rheumatoid ArthritisPhase 2dRAvite-LTENCT07620392
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
A Phase 2 study testing Afimkibart in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 12 sites in 3 countries.
Trial summary
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with… 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?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 3 Jun 2026to 8 Jul 2033
- Phase
- Phase 2
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
- Completed the treatment period of the parent study
- Agreement to adhere to the contraception requirements
- Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline
Who cannot join
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- Use of a prohibited therapy during the parent study
- Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
12 sites in 3 countries
Poland6 sites, 6 recruiting
- Recruiting
Nzoz Bif-Med
Bytom, 41-902
- Recruiting
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
Elblag, 82-300
- Recruiting
Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda
Lublin, 20-607
- Recruiting
Twoja Przychodnia NCM
Nowa Sól, 67-100
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665
- Recruiting
Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna
Wroclaw, 52-210
United States5 sites, 5 recruiting
- Recruiting
Rheumatic Disease Center
Glendale, Wisconsin, 53217
- Recruiting
Accurate Clinical Management LLC
Houston, Texas, 77089
- Recruiting
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605
- Recruiting
Arthritis and Rheumatic Disease Specialty Inc
Tamarac, Florida, 33321
- Recruiting
DM Clinical Research at Tomball
Tomball, Texas, 77375
Brazil1 site, 1 recruiting
- Recruiting
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, 36010-570
About this study
Official title: An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Afimkibart
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called PF-06480605, RVT-3101, RO7790121
Participants will receive Afimkibart as per the schedule mentioned in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart Group I | Experimental | Participants will recieve Afimkibart as subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Afimkibart Group II | Experimental | Participants will receive Afimkibart as SC injection. Receives: Drug: Afimkibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: From Baseline up to 6 years
Secondary outcomes (13)
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Measured: Up to 6 years
Change from baseline in Individual Components of ACR
Measured: Baseline, Up to 6 years
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP)
Measured: Baseline, Up to 6 years
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score
Measured: Up to 6 years
Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score
Measured: Up to 6 years
Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score
Measured: Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score
Measured: Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score
Measured: Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score
Measured: Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score
Measured: Up to 6 years
Serum Concentration of Afimkibart
Measured: Up to 6 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart at Baseline and with ADAs to Afimkibart During the Study
Measured: Baseline, Up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start3 Jun 2026
- Primary completion8 Jul 2033 (estimated)
- Study completion8 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
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
- NCT07620392
- Sponsor's protocol ID
- WA46440
- Other IDs
- 2025-523579-47-00, 2025
- Acronym
- dRAvite-LTE
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing