Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide
Brief summary
The objective of this study is to evaluate the safety of an injection of Cingal® in subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will be done by a through examination of the incidence of adverse events and physical examination of the knee.
Detailed description
The Cingal 13-02 study is a follow-on study to the recently completed clinical trial Cingal 13-01 \[NCT01891396\]. Cingal 13-01 was a multi-center, randomized, double-blind, Phase III study that enrolled 368 subjects at up to 20 sites in Canada and Europe. The Cingal 13-01 study objective was to assess the safety and effectiveness of a single injection of Cingal® for relief of joint pain and symptoms in patients with osteoarthritis (OA) of the knee. The study had three arms: the Cingal® investigational arm, an active comparator arm (Monovisc®) and a control arm (saline). Cingal 13-02 is designed to evaluate the safety of an open-label injection of Cingal® in subjects who received a study injection in the Cingal 13-01 trial. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study.
Interventions
COMBINATION_PRODUCTCingal
Injection into the knee
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Cingal 13-02 was an open label follow-up study. The participants, investigators and outcomes assessors were blinded to the specific study injection subjects had previously received in Cingal 13-01.
Intervention model description
All subjects enrolled into the Cingal 3-02 follow-on study received an intra-articular injection of Cingal. The three 'arms' of the study were for subjects who received a Cingal, Monovisc, or saline initial injection in the Cingal 13-01 study.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject completed Cingal 13-01 and is interested in participating in the follow-on study 2. Subject must be willing to abstain from other intra-articular or surgical treatments of the index knee for the duration of the study 3. Subject is willing to discontinue all analgesics except acetaminophen/paracetamol for the duration of the study 4. 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 twenty-four hours prior to the injection and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol 5. Subject is able to understand and comply with the requirements of the study and voluntarily provides consent
Exclusion criteria
1. Subject received an intra-articular injection or underwent a surgical procedure of the index knee since the study injection in Cingal 13-01 2. Subject is taking medication at the time of consent 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 and opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study. 3. 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. 4. Subject has a contraindication to IA injections, aspiration of the index knee, corticosteroids, hyaluronan, or acetaminophen/paracetamol. 5. Subject is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study. 6. Subject participated in a research study other than Cingal 13-01 within 60 days of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01 | Baseline through 6 weeks post-injection | The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02. |
Countries
Czechia, Hungary, Poland
Participant flow
Recruitment details
Subjects were recruited into Cingal 13-02 in February 2015. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study.
Pre-assignment details
All enrolled subjects were treated with Cingal in the study. There were no exclusions.
Participants by arm
| Arm | Count |
|---|---|
| Cingal/Cingal Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee | 94 |
| Cingal/Monovisc Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee | 98 |
| Cingal/Saline Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee | 50 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Cingal/Cingal | Cingal/Monovisc | Cingal/Saline |
|---|---|---|---|---|
| Age, Continuous | 59.7 Years STANDARD_DEVIATION 8.4 | 58.6 Years STANDARD_DEVIATION 8.2 | 60.2 Years STANDARD_DEVIATION 8.4 | 60.5 Years STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 242 Participants | 94 Participants | 98 Participants | 50 Participants |
| Sex: Female, Male Female | 161 Participants | 55 Participants | 68 Participants | 38 Participants |
| Sex: Female, Male Male | 81 Participants | 39 Participants | 30 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 98 | 0 / 50 |
| other Total, other adverse events | 17 / 94 | 20 / 98 | 13 / 50 |
| serious Total, serious adverse events | 0 / 94 | 1 / 98 | 0 / 50 |
Outcome results
Primary
Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.
Time frame: Baseline through 6 weeks post-injection
Population: NOTE: All subjects enrolled in Cingal 13-02 were initially also enrolled in Cingal 13-01 \[NCT01891396\]. Detail on adverse events that occurred in Cingal 13-01 \[NCT01891396\] may be found in the summary for that study on clinicaltrials.gov.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cingal 13-02 Adverse Events | Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01 | 73 Adverse events |
p-value: 0.3108Fisher Exact