Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide

• Register: ClinicalTrials.gov
• Last refreshed on: 7 March 2022
• Main ID: NCT03191903
• Date of registration: 16/06/2017
• Prospective Registration: No
• Primary sponsor: Anika Therapeutics, Inc.
• Public title: Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide
• Scientific title: Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee
• Date of first enrolment: May 25, 2017
• Target sample size: 576
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03191903
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Hungary, Poland

Contacts

• Name: Laszlo Hangody, MD
• Affiliation: Uzsoki Hospital, Department of Traumatology

Key inclusion & exclusion criteria

Inclusion Criteria:

Screening Inclusion Criteria

1. Subject is 40-75 years old, with a Body Mass Index (BMI) = 40 kg/m2.

2. Subject has Kellgren-Lawrence (K-L) severity grade I, II or III in the index knee as
determined by X-ray. Contralateral knee: K-L severity grade 0, I or II.

3. Subject has had at least two signs and at least two symptoms of OA disease (based on
the European League Against Rheumatism (EULAR) recommendations for diagnosing knee OA)
in the index knee for at least 6 months despite conservative treatment (weight
reduction, physical therapy, pain medications, etc.). The EULAR signs and symptoms are
as follows:

- Signs: crepitus, restricted movement and bony enlargement

- Symptoms: persistent knee pain, limited morning stiffness and reduced function

4. Subject must be willing to abstain from other IA treatments of the knee for the
duration of the study.

5. Subject is willing to discontinue all analgesics including NSAIDs, except
acetaminophen/paracetamol, at least seven days before the treatment injection and
through the completion of the study.

6. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams
per day per the package insert) for the treatment of joint pain for the duration of
the study. At least forty eight hours prior to the Baseline Visit and each follow-up
visit, the subject is willing to discontinue use of acetaminophen/paracetamol.

7. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin
sulfate products throughout the study, if taken prior to signing the informed consent
form (ICF).

8. Subject is able to understand and comply with the requirements of the study and
voluntarily provides consent.

Screening Exclusion Criteria:

1. Subject received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee
within 6 months of signing the informed consent form (ICF). A subject will be excluded
if they are planning to receive an HA or steroid injection (other than the study
injection) in either knee during the course of this study.

2. Subject had an arthroscopy of either knee within 3 months of signing the ICF.

3. Subject had an open surgical procedure of either knee or hip or any surgery of the
spine within 12 months of signing ICF. Subject plans to have knee, hip or spine
surgery within the study period.

4. Subject has intra-articular trauma to the index knee. Subject has concurrent
multi-system or multi-limb trauma.

5. Subject has evidence or medical history of the following diseases in the index knee:
septic arthritis; inflammatory joint disease; history of Reiter's syndrome; gout;
chondrocalcinosis associated with recurrent episodes of acute synovitis of the knee
consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone;
ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of
Wilson disease; heritable disorders or collagen gene mutations.

6. Subject has a history of cartilage repair surgery in the index knee within 3 years of
signing the ICF.

7. Subject has a history of ACL repair, reconstruction or injury in the index knee within
3 years of signing the ICF.

8. Subject has X-ray findings of acute fractures, severe bone loss, avascular necrosis,
severe bone or joint deformity in the index knee.

9. Subject has significant varus or valgus deformity greater than 10 degrees in either
knee.

10. Subject has a clinically apparent tense effusion of the index knee.

11. Subject has knee instability in either knee per the Investigator's assessment.

12. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.)
Occasional use of a cane is acceptable.

13. Subject has medical condition(s) which could affect study assessments or may adversely
affect the safety and/or success of the study treatment. This includes but is not
limited to the following: a. Peripheral neuropathy severe enough to interfere with
evaluation of the subject, b. Vascular insufficiency severe enough to interfere with
evaluation of the subject, c. Active fibromyalgia, d. Hemiparesis involving either
lower extremity, e. Immunocompromised or immunosuppressive disorder or receiving
medications to treat immunosuppressive disorders, f. Systemic bleeding disorder(s), g.
Current malignancy or treatment within the last 5 years, except for non-melanoma skin
cancer, h. Significant psychiatric disorder, i. Active drug and/or alcohol abuse
within the past year, j. Uncontrolled diabetes with a screening HbA1c of >7%.

14. Subject is taking medications at the time the subjects signs the ICF which could
interfere with the treatment procedure, healing and/or assessments. This includes but
is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet
treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular
protection is allowed if a stable regimen is maintained for the duration of the study.

15. Subject is receiving treatment using electromagnetic stimulation and/or low intensity
ultrasound in the index knee at the time of signing the ICF, within 3 months of
signing the ICF or plans to receive treatment any time during the study period.

16. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical
(excluded in index knee only) corticosteroid within 30 days of signing the ICF are
excluded. Topical corticosteroid use at any site other than the index knee is allowed.

17. Subject has a pre-treatment contraindication to IA injections or aspiration of the
index knee, including cutaneous infection in the injection site area, active IA
infection (as suggested by moderate or marked effusion), knee deformity or condition
which, in the opinion of the Investigator could jeopardize the sterility or delivery
of the IA injection.

18. Subjects with a history of hypersensitivity to any of the ingredients in the
hyaluronan or previous hypersensitivity to the administration of corticosteroids or an
inability to tolerate acetaminophen/paracetamol.

19. Subject has any contraindication to the receipt of a corticosteroid.

20. Subject is receiving or in litigation for worker's compensation.

21. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman
of child bearing potential who refuses to use effective contraception during the
course of the study.

22. Subject was involved in any other research stu


Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Intervention(s)

Device: Monovisc

Combination Product: Cingal

Drug: Triamcinolone Hexacetonide

Primary Outcome(s)

Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Secondary Outcome(s)

Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population) [Time Frame: 3 weeks]

Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population) [Time Frame: 26 weeks]

The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population) [Time Frame: 26 weeks]

Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population) [Time Frame: 1 week]

OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population) [Time Frame: 26 weeks]

Secondary ID(s)

Cingal 16-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03191903