Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI

NCT01354145 | Completed Phase 3 Results DMC

• 1 other identifier: CS/III-DMOAD-02
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 5

Brief Summary

The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Cartilage Volume Loss of the Lateral Compartment

  To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.

  12 months (Day 364) and 24 months (Day 728)

Secondary Outcomes (13)

• Cartilage Volume Loss of the Global Knee

  12 months (Day 364) and 24 months (Day 728)

• Cartilage Volume in the Medial Compartment

  12 months (Day 364) and 24 months (Day 728)

• Synovial Membrane Thickness

  Baseline, 12 months (Day 364) and 24 months (Day 728)

• Bone Marrow Lesions Score

  Baseline, 12 months (Day 364) and 24 months (Day 728)

• Synovial Fluid Volume

  Baseline, 12 months (Day 364) and 24 months (Day 728)

Study Arms (2)

Chondroitin sulfate (Condrosan)

EXPERIMENTAL

CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning

Drug: Chondroitin sulfate

Celecoxib

ACTIVE COMPARATOR

CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning

Drug: Celecoxib

Interventions

Chondroitin sulfate DRUG

Chondroitin sulphate 1200 mg/day, 24 months treatment period

Also known as: Condrosan

Chondroitin sulfate (Condrosan)

Celecoxib DRUG

Celecoxib 200 mg/day, 24 months treatment period

Celecoxib

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of either sex, aged 40 years and more
• Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion
• OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
• Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray
• VAS of pain while walking ≥ 40 mm

You may not qualify if:

• Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid \[ASA\]), lactose or NSAIDs
• Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
• Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years
• Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
• Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
• Class IV functional capacity using the American Rheumatism Association criteria
• Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit
• History of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure
• High risk of CV events, according to the AHA assessment of CV risk tables
• History of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required
• Have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
• Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline;
• Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
• Subjects who are receiving NSAID and do not want to stop during the study
• If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (5)

Institut de Rhumatologie de Montréal

Montreal, Quebec, H2L-1S6, Canada

Location

Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM)

Montreal, Quebec, J1H-5N4, Canada

Location

Groupe de Recherche en rhumatologie et maladies osseoues

Québec, Quebec, G1V-3M7, Canada

Location

Centre de Rhumatologie St. Louis

Sante Foi, Quebec, G1W-4R4, Canada

Location

Centre de Recherche musculo-squellettique

Trois-Rivières, Quebec, G8A-1Y2, Canada

Location

Related Publications (2)

• Martel-Pelletier J, Raynauld JP, Mineau F, Abram F, Paiement P, Delorme P, Pelletier JP. Levels of serum biomarkers from a two-year multicentre trial are associated with treatment response on knee osteoarthritis cartilage loss as assessed by magnetic resonance imaging: an exploratory study. Arthritis Res Ther. 2017 Jul 20;19(1):169. doi: 10.1186/s13075-017-1377-y.

  PMID: 28728606 DERIVED

• Pelletier JP, Raynauld JP, Beaulieu AD, Bessette L, Morin F, de Brum-Fernandes AJ, Delorme P, Dorais M, Paiement P, Abram F, Martel-Pelletier J. Chondroitin sulfate efficacy versus celecoxib on knee osteoarthritis structural changes using magnetic resonance imaging: a 2-year multicentre exploratory study. Arthritis Res Ther. 2016 Nov 3;18(1):256. doi: 10.1186/s13075-016-1149-0.

  PMID: 27809891 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin Sulfates; Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Marta Herrero - Clinical R&D Manager
• Organization: Bioiberica

mherrero@bioiberica.com

+34934904908

Study Officials

• Jean-Pierre Pelletier, MD

  Principal Author

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 16, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 19, 2016
• Results First Posted: August 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)