A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with MTX in participants with moderately to severely active RA who have an inadequate response to MTX.

  • STATUS
    Recruiting
Updated on 23 November 2020
tofacitinib

Summary

A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with MTX in participants with moderately to severely active RA who have an inadequate response to MTX.

 

Description

  • Otilimab vs Tofacitinib vs Placebo
  • 6:6:3:1:1:1 Ratio.
  • 52 Wks
  • 13 Visits
  • Otilimab (also known as GSK3196165) is a study drug that is an antibody therapy and is given as an injection. Antibodies produced by our bodies are proteins that fight against intruders. Antibody medications, such as Otilimab, are made in the laboratory and look like antibodies made by your body, except they specifically block certain substances. Otilimab blocks a specific chemical messenger called granulocyte-macrophage colony-stimulating factor (GM-CSF). Higher levels of GM-CSF are found in the joints of people with RA. It is thought that blocking GM-CSF will reduce symptoms and slow progression of RA.
  • Tofacitinib is a FDA approved medication for treating RA that is taken by mouth. It blocks the effect of a chemical messenger called Janus kinase (JAK) involved in the inflammation of joints in RA. Sometimes, tofacitinib is prescribed in combination with methotrexate.

Details
Condition Rheumatoid Arthritis
Clinical Study IdentifierTX230590
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

RA ≥6 mo. at time of screening and not dx before 16 years of age
Active disease at both screening and baseline (both ≥6/68 (TJC), ≥6/66 (SJC))
Must be on MTX (15-25 mg oral or inj.) for ≥12 wks at the max. tolerated dose, and stable for at least 8 wks prior to Day 1. A lower dose of ≥7.5 mg/wk is acceptable if intolerant

Exclusion Criteria

Any prior tx to antagonising GM-CSF or its receptor
Any prior tx with targeted synthetic DMARDs including JAK inhibitors
Any prior tx with a biologic DMARD which has been discontinued due to an IR
Active infections (incl, localized infections), or history of recurrent infections
Currently taking any suppressive anti-infective tx for a chronic infection OR history of infected joint prosthesis at any time, with the prosthesis still in situ. Hx of chronic leg ulcers, permanent in-dwelling catheters, chronic sinusitis, recurrent chest infections or recurrent UTIs
Breast cancer ≤10 years. Malignancy ≤5 years (incl. lymphoma, leukaemia). Exception: Cervical carcinoma in situ or basal cell/squamous cancers ≤3 years
Hx of other inflammatory rheumatologic or systemic autoimmune disorder (MCTD, PsA, juvenile chronic arthritis, spondyloarthritis, Felty's Syn., SLE, Scleroderma, Crohn's disease, ulcerative colitis, or vasculitis. Secondary Sjogren's syndrome is allowed
Dx of FMS that, in the investigator's opinion, would make it difficult to assess RA activity for the purposes of this study
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note