DATA SHEET OF CLINICAL TRIAL C.T. No 005-99

CLINICAL TRIAL REGISTRATION (EC)

I. SPONSOR INFORMATION

Foreign National

2. LEGAL PERSON 2.1 FOREIGN SPONSOR Registered Name: PFIZER S.A. Registered Tradename: PFIZER S.A. FOREIGN SPONSOR REPRESENTATIVE IN PERU

SUBSIDIARY: BRANCH: CRO: OTHER: ______Tradename: N/A TYPE OF INSTITUTION Laboratorio (Industria Farmacéutica)

II. CLINICAL TRIAL GENERAL INFORMATION

1. CLINICAL TRIAL IDENTIFICATION Scientific Title: CLINICAL PROTOCOL FOR EFFICACY AND SAFETY STUDIES OF CELECOXIB SUCESIVE IN OSTEOARTHRITIS: SUCCESS-1 Public Title: N.A. Secundary ID(s): WHO UTN: N/A Protocol Code: 149-98-02-096, US IND 48,395 Clinicaltrials.gov: NA EUDRACT N°: NA

1 1-2 2 2-3 Study clinical phase: 3 4 Clinical Trial Total Duration: 12 months No Aplica 0(exploratory trials) Enrolment start date in Peru (Initial) 01/01/1900 Worldwide enrolment start date (dd/ (dd/mm/aaaa): 01/01/1900 mm/aaaa): Enrolment start date in Peru (Posterior) (dd/mm/aaaa):

Without starting enrollment In enrollment Peru enrolment status : Enrollment stopped Enrollment closed Other 2. CLINICAL TRIAL GOALS AND DESIGN

Randomnized Simple Non randomnized Double Assignation method Type of blinding No aplica Triple Open

Single arm Parallel Crossed Factorial Assignation Others: ______Study Design Multi-center, multinational study, of 12 weeks duration, double blind, randomized, 3-arm, with active comparator and parallel groups in patients with osteoarthritis (OA) of the knee, hip or hand. The study will compare, in different countries / regions, the efficacy and tolerability of 100 mg of celecoxib given twice a day or 200 mg of celecoxib administered twice a day with the NSAID used as a comparator (diclofenac 50 mg 2 times a day or naproxen -500 mg 2 times a day). Purpose The main objectives of this study are: • Compare the effectiveness in different countries and / or geographical regions • Evaluate the homogeneity of effectiveness between different countries and / or regions; and • To compare the general tolerability and clinical safety of celecoxib 100 mg BID, 200 mg BID with two comparative NSAIDs (diclofenac 50 mg twice daily and naproxen 500 mg twice daily) in the treatment of signs and symptoms of osteoarthritis of the knee and hip. 3. STUDY INTERVENTION

Página 1 de 4 Indicate if the product is being developed as: Pharmaceutical product Medical device Herbal product Type of research product Galenic product Complementary product Dietary product and sweetener Other: ______Research product identification N° Product name Generic name Product type ATC 1 Celecoxib 100mg Celecoxib 100mg Producto en investigación de origen M01 - Productos tópicos químico antiinflamatorios y antirreumáticos

N° Comparator name Generic name Product type ATC 1 Diclofenaco Diclofenaco Medicamento M01 - Productos tópicos antiinflamatorios y antirreumáticos Intervention(s) description: N° of Group Name Type of group Intervention(s) description participants

Subjects' treatment time 12 weeks Subjects' follow up time 0 months 4. Study Population Inclusion Criteria: 1. 1. Male or female age >18 years and legal age to give consent; 2. Female patients must be postmenopausal or surgically sterilized or an analysis of pregnancy in the urine with a negative result within 7 days prior to randomization and should use an appropriate contraceptive method during the study; Nor can they meet during the breastfeeding period. 3. Clinical diagnosis of osteoarthritis of the hip or knee or the hand according to the ACR Osteoarthritis Classification Criteria (see Appendix 5) at least 6 months before randomization. 4. At the investigator´s discretion, that the patient requires and is: in conditions of undergoing a chronic treatment (daily) with an NSAID and / or with analgesics to control the symptoms of arthritis. If the patient was already taking NSAIDs, they should benefit from the treatment change. 5. Classification of the functional capacity of I-III (see Appendix 5). 6. That the patient has given written informed consent before admission to the study. Exclusion Criteria: 1. 1. If the patient has a history of two or more isolated episodes of active peptic ulcer, gastrointestinal hemorrhage or recurrent or duodenal ulcer. 2. If the patient had esophageal, gastric or duodenal ulcers within 30 days prior to randomization. 3. Active GI disease (eg, Crohn´s disease or ulcerative colitis) or any other disease that in the opinion of the researcher, could be an impediment to the use of an NSAID. 4. If the patient had any malignancy, whatever type (excluding basal cell carcinoma). 5. History of renal or hepatic disease of clinical importance that, in the opinion of the investigator, could be an impediment to participate in the study, for example, that in the past serum creatinine was> 2.0 mg / dL or> 177 pmol / L or that the ALT (SGPT) or the ASI (SGOT) were three times higher than the upper normal limit. 6. If the patient received an intraarticular or intramuscular corticosteroid or a joint injection of hyaluronic acid within 8 weeks prior to randomization. 7. It is anticipated that the patient may need any of the following medications during the study: a. Intra-articular or intramuscular corticosteroid or joint injection of hyaluronic acid; b. medicines for arthritis, including over-the-counter preparations, other than study medications. (Note: an aspirin <325 mg / day is allowed as a cardiac protection). c. Chronic use (daily or practically daily) of analgesics. (Note: only paracetamol or paracetamol is allowed casual, for example for the headache) d. , salts, , antimalarials, , or ciclosporin. e. Anti-ulcer drugs, including the chronic use (daily or practically daily) of antacids. (Note: occasional use of antacids will be allowed during the study) f. Oral corticosteroids. 8. Known hypersensitivity to celecoxib, sulfonamides or any NSAID such as asthma, urticaria or acute rhinitis caused by aspirin or other NSAIDs. 9. If the patient has received any investigational medication within 30 days prior to the first dose of the study medication or if he intends to receive a research drug other than celecoxib during the course of this study. 10. If the patient had been previously admitted in this study. Studied Condition: Osteoartritis de la cadera o de la rodilla o de la mano Studied Condition N/A Medical speciality : Rheumatology classification(CIE-10): Countries where the enrolment is conducted: Number of participants per gender 0 >Number of subjects to be included (Initial): 0 in all the countries: Number of participants per gender 0 (Posterior):

Population to be included by gender Women Men Both

Healthy volunteers Yes No

Subordinate Groups Yes No

Indigenous or native people Yes No

Minors Yes No Indicate if the study population Subjects with disabilities to grant consent includes: Yes No Women of childbearing age Yes No

Pregnant women Yes No

Women during labor, puerperium or lactation Yes No

Fetus Yes No

Range of age of subjects to be Adults(18-64 years) Yes No included: Elderly (>= 65 years) Yes No

Página 2 de 4 Under 18 years Yes No

- In Utero Yes No

- Preterm newborn infants (up to gestational age < 37 weeks) Yes No

- Newborns (0-27 days) Yes No

- Infants and toddlers (28 days-23months) Yes No

- Children (2 - 11 years) Yes No

- Adolescents (12 - 17 years) Yes No 5. EVALUATION CRITERIA Primary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement 1 Primary Variables of Arthritis Efficacy It will be evaluated in comparison with the values obtained 6 weeks 12 weeks in the premedication. • Overall evaluation of arthritis by the patient: it will be rated with a scale of 5 points. • Overall assessment of arthritic pain on the part of the patient (EVA): it will be evaluated using a 5-point scale. • WOMAC (Universities of Western Ontario and McMaster) will be evaluated only in those countries in which this index is applied. Secondary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement It will be evaluated in comparison with the values obtained in the first visit. • General evaluation of arthritis by the 1 Secondary Variables of Arthritis Efficacy 6 weeks 12 weeks doctor; and • Evaluation of night pain by the patient (from WOMAC)

6. DATA MONITORING Existence of the Data Monitoring ¿Interim analysis is planned? Yes No Committee(CMD) Yes No

III. INFORMATION FROM THE FINANCING SOURCE

1. INFORMATION FROM THE FINANCING SOURCE Sponsor Name PFIZER S.A. 2. Sponsor Responsibilities Institution Name Responsibility N/A Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country. N/A Submit progress reports to the National Health Institute during the execution of the Clinical Trial. N/A Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial. N/A Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation. N/A Inform and describe the reasons for a suspension and cancellation of the clinical trial. N/A Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health. N/A False

IV. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE

Research Site 1 of 1 1. RESEARCH SITE WHERE THE CLINICAL TRIAL WILL BE CONDUCTED HOSPITAL NACIONAL CAYETANO RCI N°: 00527 Research site: HEREDIA - Servicio de Endocrinología 2. PRINCIPAL INVESTIGATOR Full name: Armando Augusto, Calvo Quiroz 3. CO-INVESTIGATOR 4. INSTITUTIONAL RESEARCH ETHICS COMMITTEE (CIEI) THAT APPROVED THE TRIAL FOR THE SITE

Página 3 de 4 UNIVERSIDAD PERUANA CAYETANO HEREDIA - Comité Institucional de Ética en RCIEI N°: 00014 Ethics Committe Name: Investigación - CIEI de la Universidad Peruana Cayetano Heredia - UPCH Approval date: 25/05/1999 End approval date: CONTACT DATA (Legal Representative of CIEI) Full Name: Humberto Antonio, Guerra Allison E-mail: [email protected] Av. Honorio Delgado 430 Urb. I Telephone number: 3190000 anexo 2271 Address: (Lima - Lima - San Martin de Porres)

VI. SHARED USE OF CLINICAL TRIAL DATA (ANONIMIZED INDIVIDUAL DATA)

¿Is there a plan for sharing of Yes No Not decided deidentified individual clinical trial participant-level data (IPD) to other In case the answer is affirmative, describe the Plan: researchers (including data dictionaries)? None

Study protocol Statistical Analysis Plan Informed consent form Additional information that will be Clinical Study Report shared Others ______(Inglés) Describe briefly when this information will be available and how it can be obtained. N/A URL N/A DOI N/A Clinical Trial Registration Date 25-08-1999 00:00 Most recent Clinical Trial Update N/A

VII. CLINICAL TRIAL CONTACT PERSONS INFORMATION

DATA OF THE CONTACT PERSON(s) FOR CONSULTATIONS ABOUT THE CLINICAL TRIAL Full Name Email Telephone Type of queries to be resolved

VIII. AUTORIZATION STATUS

RESOLUCIÓN DIRECTORAL Document Document Date 25/08/1999 034-1999 Observations

Instituto Nacional de Salud - 06/10/2021 8:19 a.m.

Página 4 de 4