ASTUTE Trial: Adalimumab versus placebo for the treatment of uveitis, an autoimmune eye disease.

Phase 1

• Conditions: Autoimmune non-infectious uveitis (ANIU); MedDRA version: 20.0Level: PTClassification code 10075690Term: Autoimmune uveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-000754-97-GB
• Lead Sponsor: niversity Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-11
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients must:
(a) present with active sight-threatening ANIU in either or both eyes and who are taking oral prednisolone >5mg/day or being started on steroids >5mg/day, or

(b) those in remission taking >5mg/day of oral prednisolone and other immunomodulatory therapy drugs as required.

In the subgroup presenting with new active disease, remission will be induced with high dose oral prednisolone; oral prednisolone will be tapered to less than or equal to 5mg/day over 16 weeks in both groups. The treatment goal in the treatment run-in is the same for both groups, i.e. disease remission with less than or equal to 5mg/day oral prednisolone. If achieved by the end of the treatment run-in, participants will be eligible for randomisation.

To be eligible for the trial, including the 'treatment run-in', all of the following must apply:

1. Participant is aged 18 years or over;

2. Participant has: (a) active sight threatening ANIU (active inflammatory chorioretinal lesions OR abnormal central macular thickness (CMT) OR evidence of retinal vasculitis OR vitreous haze >0.5) and is being prescribed (already taking or being started on, if newly presenting with ANIU) oral prednisolone >5.0mg/day; OR (b) has controlled ANIU and is being prescribed oral prednisolone >5.0mg/day;

3. Women must have a negative pregnancy test and be willing to use effective contraception* for the duration of the participation in the trial and for 5 months after, or be surgically sterile or post-menopausal for >12 months;

4. Participant is able to provide informed consent.

* this includes: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide cap, diaphragm or sponge with spermicide, combined (eostrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation: (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

A participant may not enter the trial, including the 'treatment run-in' if any of the following apply:

1. Participant has controlled ANIU and is maintained on corticosteroids =5.0 mg/day at the time of screening;

2. Participant has systemic disease (whether associated with ANIU or not) that is being treated with steroids and requires >5mg/day oral prednisolone;

3. Participant has untreated or active tuberculosis;

4. Participant has severe infection, sepsis or opportunistic infection;

5. Participant has uncontrolled glaucoma;

6. Participant has multiple sclerosis;

7. Participant is HIV positive;

8. Participant has hepatitis B or hepatitis C

9. Participant has syphilis

10. Participant has Lyme disease

11. Participant has Behcet’s disease

12. Participant has toxoplasmosis chorioretinitis

13. Participant has heart failure (NYHA III/IV)

14. Participant has been diagnosed with cancer <5 years ago

15. Participant is undergoing monitoring for recurrence of cancer / tumour growth where their oncologist has concern that a TNFalpha inhibitor would be contraindicated

16. Participant is taking another biologic drug;

17. Participant has taken an anti-TNF drug within the previous 90 days (anakinra and abatacept are contraindicated);

18. Participant has had an Iluvien® implant within the previous 18 months and has controlled ANIU, or has had an Iluvien® implant within the previous 12 weeks regardless of whether ANIU is active or controlled;

19. Participant has had an Ozurdex® implant, or an intravitreal steroid injection, or periocular steroid within the previous 12 weeks regardless of whether ANIU is active or controlled;

20. Participant is pregnant;

21. Participant has a known allergy or hypersensitivity to adalimumab or any of its excipients;

22. Participant is taking part in another interventional study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified