Painful Inflammatory Carpometacarpal-1 osteoArthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Diakonhjemmet Sykehus AS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

3 Nov 2023 → ongoing

Decision date (initial)

2023-09-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To assess whether intraarticular corticosteroid (IACS) injections are superior to saline injections after 4 weeks, and compare the efficacy of IACS injections, saline injections and a multimodal occupational therapy intervention after 12 weeks in patients with painful inflammatory OA in the first carpometacarpal joint.

Secondary objectives 5

1. Effect of interventions on pain, physical function, stiffness, grip strength, disease activity, self-efficacy, patient satisfaction and health-related quality of life
2. Effect of interventions on inflammation and bone marrow lesions
3. Effect of interventions on structural progression
4. Adverse events of interventions
5. Effect of interventions on cost-effectiveness

Conditions and MedDRA coding

Osteoarthritis in first carpometacarpal joint

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Men and women between 40-85 years of age
2. Osteoarthritis in target CMC-1 joint confirmed by radiographs or ultrasound examination
3. Inflammation in target CMC-1 joint confirmed by ultrasound (grey scale synovitis grade 1-3)
4. Pain in target CMC-1 joint of at least 3 on a 0-10 Numeric rating scale (NRS) at rest or during activities at both pre-screening and screening
5. Patient is assessed as eligible for the proposed use of Kenacort-T

Exclusion criteria 20

1. Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks
2. Intraarticular injections in the target CMC-1 joint in the last 12 weeks
3. More than three previous IACS injections in the target CMC-1 joint
4. Use of oral, intramuscular, or intravenous steroids in the last 12 weeks
5. Previous surgery of the target CMC-1 joint
6. Planned hand surgery in the coming 24 weeks
7. Refuse to quit using oral or topical NSAIDs on the hands (such as ibuprofen, diclofenac, etoricoxib, naproxen) in the next 12 weeks
8. Systemic inflammatory joint diseases (including but not limited to rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis/trigger finger)
9. Diagnosis of fibromyalgia
10. Diagnosis of psoriasis
11. Infection, skin disease or wounds at joint injection site
12. Serious comorbidities, cognitive dysfunction, substance/alcohol abuse or any other medical condition that makes adherence to the study protocol difficult
13. Severe or uncontrolled infections
14. Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid)
15. Use of digitalis glycosides
16. Included in another clinical study
17. Patients vaccinated or immunized with live virus vaccines in the last 2 weeks
18. Not being able to speak or understand Norwegian
19. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
20. Known pregnancy or planned pregnancy in the next 6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 4 weeks
2. Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 12 weeks

Secondary endpoints 29

1. Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) (all visits)
2. Change in finger joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
3. Change in Australian/Canadian Ostearthritis Hand Index (AUSCAN) pain, stiffness and function subscales (W00, W04, W12, W24, W104)
4. Number of OMERACT-OARSI criteria responders (W00, W04, W12, W24, W104)
5. Change in measure of activity performance of the hand (MAP-Hand) (W00, W04, W12, W24, W104)
6. Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
7. Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
8. Change in pain in finger joints last 24 hours (hand figure) (W00, W04, W12, W24, W104)
9. Change in grip strength (W00, W04, W12, W24, W104)
10. Change in use of analgesics (W00, W04, W12, W24, W104)
11. Change in use of NSAIDs (W00, W04, W12, W24, W104)
12. Change in arthritis self-efficacy scale (W00, W04, W12, W24, W104)
13. Number of responders regarding patient satisfaction (W04, W12)
14. Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L) (W00, W04, W12, W24, W104)
15. Change in number of tender hand joints (W00, W04, W12, W24, W104)
16. Change in number of swollen hand joints (W00, W04, W12, W24, W104)
17. Change in ultrasound synovitis in the CMC-1 joint (W00, W04, W12, W24, INJ, W104)
18. Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI (W00, W04)
19. Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI (W00, W04)
20. Change in structural progression by Kellgren-Lawrence (W00, W104)
21. Change in osteophytes by OARSI atlas (W00, W104)
22. Change in joint space narrowing by OARSI atlas (W00, W104)
23. Change in subluxation of the CMC-1 joint (W00, W104)
24. Number of adverse events (W00, W04, W12, W24, INJ, W104)
25. Number of serious adverse events (W00, W04, W12, W24, INJ, W104)
26. Number of withdrawals because of adverse events (W04, W12, W24, INJ, W104)
27. Questions about use of healthcare services (W00, W12, W24, W104)
28. Change in thumb base joint pain at rest last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
29. Change in finger joint pain at rest last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Diakonhjemmet Sykehus AS

Sponsor organisation

Diakonhjemmet Sykehus AS

Address

Diakonveien 12

City

Oslo

Postcode

0370

Country

Norway

Scientific contact point

Organisation

Diakonhjemmet Sykehus AS

Contact name

Sponsor contact person

Public contact point

Organisation

Diakonhjemmet Sykehus AS

Contact name

Sponsor contact person

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications